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This repository is under review for potential modification in compliance with Administration directives.

Details

Stereochemistry ABSOLUTE
Molecular Formula C18H21NO3.C4H6O6
Molecular Weight 449.4511
Optical Activity UNSPECIFIED
Defined Stereocenters 6 / 6
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of HYDROCODONE BITARTRATE ANHYDROUS

SMILES

O[C@H]([C@@H](O)C(O)=O)C(O)=O.COC1=C2O[C@H]3C(=O)CC[C@H]4[C@H]5CC(C=C1)=C2[C@@]34CCN5C

InChI

InChIKey=OJHZNMVJJKMFGX-BWCYBWMMSA-N
InChI=1S/C18H21NO3.C4H6O6/c1-19-8-7-18-11-4-5-13(20)17(18)22-16-14(21-2)6-3-10(15(16)18)9-12(11)19;5-1(3(7)8)2(6)4(9)10/h3,6,11-12,17H,4-5,7-9H2,1-2H3;1-2,5-6H,(H,7,8)(H,9,10)/t11-,12+,17-,18-;1-,2-/m01/s1

HIDE SMILES / InChI

Molecular Formula C4H6O6
Molecular Weight 150.0868
Charge 0
Count
Stereochemistry ABSOLUTE
Additional Stereochemistry No
Defined Stereocenters 2 / 2
E/Z Centers 0
Optical Activity UNSPECIFIED

Molecular Formula C18H21NO3
Molecular Weight 299.3642
Charge 0
Count
Stereochemistry ABSOLUTE
Additional Stereochemistry No
Defined Stereocenters 4 / 4
E/Z Centers 0
Optical Activity UNSPECIFIED

Benzhydrocodone is a prodrug of hydrocodone. Benzhydrocodone is formed by covalently bonding hydrocodone to benzoic acid. Benzhydrocodone itself is not pharmacologically active, but must be metabolized to hydrocodone by enzymes in the intestinal tract to optimally deliver its pharmacologic effects. Hydrocodone is a full agonist of the opioid receptors with a higher affinity for the mu-opioid receptor. Upon binding, hydrocodone produces an analgesic effect with no ceiling. APADAZ a combination of benzhydrocodone and acetaminophen is FDA approved and indicated for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. APADAZ, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death.

Approval Year

Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
ZOHYDRO ER

Approved Use

ZOHYDRO ER is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Launch Date

2013
Primary
APADAZ

Approved Use

APADAZ is a combination of benzhydrocodone, a prodrug of the opioid agonist hydrocodone, and acetaminophen, and is indicated for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Launch Date

2019
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
13 ng/mL
15 mg single, oral
dose: 15 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
HYDROCODONE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
10.1 ng/mL
15 mg single, oral
dose: 15 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
HYDROCODONE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
23.6 ng/mL
10 mg single, oral
dose: 10 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
16.04 ng/mL
6.12 mg single, oral
dose: 6.12 mg
route of administration: Oral
experiment type: SINGLE
co-administered: ACETAMINOPHEN
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: HIGH-FAT
19.18 ng/mL
6.12 mg single, oral
dose: 6.12 mg
route of administration: Oral
experiment type: SINGLE
co-administered: ACETAMINOPHEN
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: HIGH-FAT
33.95 ng/mL
12.24 mg 6 times / day multiple, oral
dose: 12.24 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered: ACETAMINOPHEN
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
62.79 ng/mL
12.24 mg 6 times / day multiple, oral
dose: 12.24 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered: ACETAMINOPHEN
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
208 ng/mL
73.44 mg single, oral
dose: 73.44 mg
route of administration: Oral
experiment type: SINGLE
co-administered: ACETAMINOPHEN
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
9.4 ng/mL
6.12 mg single, nasal
dose: 6.12 mg
route of administration: Nasal
experiment type: SINGLE
co-administered: ACETAMINOPHEN
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
27 ng/mL
24.48 mg single, nasal
dose: 24.48 mg
route of administration: Nasal
experiment type: SINGLE
co-administered: ACETAMINOPHEN
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
25.6 ng/mL
12.24 mg single, nasal
dose: 12.24 mg
route of administration: Nasal
experiment type: SINGLE
co-administered:
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
40.4 ng/mL
12.24 mg single, oral
dose: 12.24 mg
route of administration: Oral
experiment type: SINGLE
co-administered: ACETAMINOPHEN
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
34.7 ng/mL
12.24 mg single, nasal
dose: 12.24 mg
route of administration: Nasal
experiment type: SINGLE
co-administered: ACETAMINOPHEN
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
269 ng × h/mL
15 mg single, oral
dose: 15 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
HYDROCODONE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
155 ng × h/mL
15 mg single, oral
dose: 15 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
HYDROCODONE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
130.91 ng × h/mL
6.12 mg single, oral
dose: 6.12 mg
route of administration: Oral
experiment type: SINGLE
co-administered: ACETAMINOPHEN
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: HIGH-FAT
125.73 ng × h/mL
6.12 mg single, oral
dose: 6.12 mg
route of administration: Oral
experiment type: SINGLE
co-administered: ACETAMINOPHEN
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: HIGH-FAT
92.94 ng × h/mL
12.24 mg 6 times / day multiple, oral
dose: 12.24 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered: ACETAMINOPHEN
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
195.07 ng × h/mL
12.24 mg 6 times / day multiple, oral
dose: 12.24 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered: ACETAMINOPHEN
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
1272 ng × h/mL
73.44 mg single, oral
dose: 73.44 mg
route of administration: Oral
experiment type: SINGLE
co-administered: ACETAMINOPHEN
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
194.7 ng × h/mL
12.24 mg single, nasal
dose: 12.24 mg
route of administration: Nasal
experiment type: SINGLE
co-administered:
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
252.7 ng × h/mL
12.24 mg single, oral
dose: 12.24 mg
route of administration: Oral
experiment type: SINGLE
co-administered: ACETAMINOPHEN
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
278.3 ng × h/mL
12.24 mg single, nasal
dose: 12.24 mg
route of administration: Nasal
experiment type: SINGLE
co-administered: ACETAMINOPHEN
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
10.5 h
15 mg single, oral
dose: 15 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
HYDROCODONE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
10.2 h
15 mg single, oral
dose: 15 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
HYDROCODONE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
4 h
10 mg single, oral
dose: 10 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
4.51 h
6.12 mg single, oral
dose: 6.12 mg
route of administration: Oral
experiment type: SINGLE
co-administered: ACETAMINOPHEN
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: HIGH-FAT
4.33 h
6.12 mg single, oral
dose: 6.12 mg
route of administration: Oral
experiment type: SINGLE
co-administered: ACETAMINOPHEN
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: HIGH-FAT
4.45 h
12.24 mg 6 times / day multiple, oral
dose: 12.24 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered: ACETAMINOPHEN
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
4.87 h
12.24 mg 6 times / day multiple, oral
dose: 12.24 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered: ACETAMINOPHEN
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
5 h
73.44 mg single, oral
dose: 73.44 mg
route of administration: Oral
experiment type: SINGLE
co-administered: ACETAMINOPHEN
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
5.29 h
12.24 mg single, nasal
dose: 12.24 mg
route of administration: Nasal
experiment type: SINGLE
co-administered:
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
55%
10 mg single, oral
dose: 10 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
HYDROCODONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
Doses

Doses

DosePopulationAdverse events​
30 mg multiple, oral
Overdose
Dose: 30 mg
Route: oral
Route: multiple
Dose: 30 mg
Sources:
unhealthy, 5 years
Health Status: unhealthy
Age Group: 5 years
Sex: F
Sources:
Other AEs: Adverse event...
Other AEs:
Adverse event (grade 5)
Sources:
160 mg 1 times / day multiple, oral
Highest studied dose
unhealthy, adult
Other AEs: Electrocardiogram QTc interval prolonged...
20 mg 1 times / day multiple, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg, 1 times / day
Sources:
pregnant, adult
Health Status: pregnant
Age Group: adult
Sex: F
Sources:
Other AEs: Withdrawal syndrome neonatal...
20 mg 1 times / day multiple, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
Other AEs: Respiratory depression, Addiction...
Other AEs:
Respiratory depression (grade 5)
Addiction
Sources:
20 mg 1 times / day multiple, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Disc. AE: Vomiting, Nausea...
AEs leading to
discontinuation/dose reduction:
Vomiting (1%)
Nausea (1%)
Headache (1%)
Dizziness (1%)
Sources:
13.34 mg 1 times / day steady-state, intranasal
Studied dose
Dose: 13.34 mg, 1 times / day
Route: intranasal
Route: steady-state
Dose: 13.34 mg, 1 times / day
Sources:
healthy, ADULT
Health Status: healthy
Age Group: ADULT
Sex: M+F
Food Status: UNKNOWN
Sources:
Other AEs: Nasal discomfort, Nasal congestion...
Other AEs:
Nasal discomfort (16 patients)
Nasal congestion (7 patients)
Rhinorrhea (7 patients)
Throat irritation (6 patients)
Oropharyngeal pain (1 pt)
Dry throat (1 pt)
Sources:
AEs

AEs

AESignificanceDosePopulation
Adverse event grade 5
30 mg multiple, oral
Overdose
Dose: 30 mg
Route: oral
Route: multiple
Dose: 30 mg
Sources:
unhealthy, 5 years
Health Status: unhealthy
Age Group: 5 years
Sex: F
Sources:
Electrocardiogram QTc interval prolonged
160 mg 1 times / day multiple, oral
Highest studied dose
unhealthy, adult
Withdrawal syndrome neonatal
20 mg 1 times / day multiple, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg, 1 times / day
Sources:
pregnant, adult
Health Status: pregnant
Age Group: adult
Sex: F
Sources:
Addiction
20 mg 1 times / day multiple, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
Respiratory depression grade 5
20 mg 1 times / day multiple, oral
Recommended
Dose: 20 mg, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
Dizziness 1%
Disc. AE
20 mg 1 times / day multiple, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Headache 1%
Disc. AE
20 mg 1 times / day multiple, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Nausea 1%
Disc. AE
20 mg 1 times / day multiple, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Vomiting 1%
Disc. AE
20 mg 1 times / day multiple, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: multiple
Dose: 20 mg, 1 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Dry throat 1 pt
13.34 mg 1 times / day steady-state, intranasal
Studied dose
Dose: 13.34 mg, 1 times / day
Route: intranasal
Route: steady-state
Dose: 13.34 mg, 1 times / day
Sources:
healthy, ADULT
Health Status: healthy
Age Group: ADULT
Sex: M+F
Food Status: UNKNOWN
Sources:
Oropharyngeal pain 1 pt
13.34 mg 1 times / day steady-state, intranasal
Studied dose
Dose: 13.34 mg, 1 times / day
Route: intranasal
Route: steady-state
Dose: 13.34 mg, 1 times / day
Sources:
healthy, ADULT
Health Status: healthy
Age Group: ADULT
Sex: M+F
Food Status: UNKNOWN
Sources:
Nasal discomfort 16 patients
13.34 mg 1 times / day steady-state, intranasal
Studied dose
Dose: 13.34 mg, 1 times / day
Route: intranasal
Route: steady-state
Dose: 13.34 mg, 1 times / day
Sources:
healthy, ADULT
Health Status: healthy
Age Group: ADULT
Sex: M+F
Food Status: UNKNOWN
Sources:
Throat irritation 6 patients
13.34 mg 1 times / day steady-state, intranasal
Studied dose
Dose: 13.34 mg, 1 times / day
Route: intranasal
Route: steady-state
Dose: 13.34 mg, 1 times / day
Sources:
healthy, ADULT
Health Status: healthy
Age Group: ADULT
Sex: M+F
Food Status: UNKNOWN
Sources:
Nasal congestion 7 patients
13.34 mg 1 times / day steady-state, intranasal
Studied dose
Dose: 13.34 mg, 1 times / day
Route: intranasal
Route: steady-state
Dose: 13.34 mg, 1 times / day
Sources:
healthy, ADULT
Health Status: healthy
Age Group: ADULT
Sex: M+F
Food Status: UNKNOWN
Sources:
Rhinorrhea 7 patients
13.34 mg 1 times / day steady-state, intranasal
Studied dose
Dose: 13.34 mg, 1 times / day
Route: intranasal
Route: steady-state
Dose: 13.34 mg, 1 times / day
Sources:
healthy, ADULT
Health Status: healthy
Age Group: ADULT
Sex: M+F
Food Status: UNKNOWN
Sources:
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG



OverviewOther

Other InhibitorOther SubstrateOther Inducer


Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
minor
minor
yes
yes (co-administration study)
Comment: The 90% confidence interval (CI) of the geometric means for hydrocodone AUCinf (98 to 115%), AUCt (98 to 115%), and Cmax (93 to 121%) values were within the range of 80 to 125% when a single dose of HYSINGLA ER 20 mg was co-administered with CYP2D6 inhibitor paroxetine
yes
yes (co-administration study)
Comment: Co-administration of HYSINGLA ER and CYP3A4 inhibitor ketoconazole increased mean hydrocodone AUC and Cmax by 135% and 78%, respectively;
Tox targets

Tox targets

TargetModalityActivityMetaboliteClinical evidence
PubMed

PubMed

TitleDatePubMed
Opioid formulations: tailoring to the needs in chronic pain.
2001
Harmonic Scalpel vs. electrocautery hemorrhoidectomy: a prospective evaluation.
2001 Apr
Psychosis after ultrarapid opiate detoxification.
2001 Jun
Narcotic analgesics for dental pain: available products, strengths, and formulations.
2001 Mar-Apr
Important drugs for cough in advanced cancer.
2001 Nov
Acetaminophen, aspirin, or Ibuprofen in combination analgesic products.
2001 Nov-Dec
Rofecoxib versus codeine/acetaminophen in postoperative dental pain: a double-blind, randomized, placebo- and active comparator-controlled clinical trial.
2001 Sep
Complications of intranasal prescription narcotic abuse.
2002 Feb
The effectiveness of an anesthetic continuous-infusion device on postoperative pain control.
2002 Jan
Synthesis and biological activity of 8beta-substituted hydrocodone indole and hydromorphone indole derivatives.
2002 Jan 21
Gateways to clinical trials.
2002 Jul-Aug
A double-blind, single-dose comparison of the analgesic efficacy of tramadol/acetaminophen combination tablets, hydrocodone/acetaminophen combination tablets, and placebo after oral surgery.
2002 Jun
[Trends in the incidence of hepatic tumors in childhood].
2002 Mar-Apr
Detection of cocaine analytes and opiates in nails from postmortem cases.
2002 Oct
[Hypoxic brain damage in victims of fatal road traffic accident: prevalence, distribution and association with survival time and other head and extracranial injuries].
2002 Sep
Review of the analgesic efficacy of ibuprofen.
2003 Apr
Current concepts in acute pain management.
2003 May
[Spanish scientific production in anesthesiology and resuscitation 1983-1995].
2003 Nov
Withdrawal hyperalgesia after acute opioid physical dependence in nonaddicted humans: a preliminary study.
2003 Nov
The influence of gender and race on physicians' pain management decisions.
2003 Nov
Refractory status epilepticus.
2004 Feb
Effective treatment of laparoscopic cholecystectomy pain with intravenous followed by oral COX-2 specific inhibitor.
2004 Feb
Activation of G-proteins by morphine and codeine congeners: insights to the relevance of O- and N-demethylated metabolites at mu- and delta-opioid receptors.
2004 Feb
Postoperative pain management after anterior cruciate ligament reconstruction.
2004 Jan
Patient characteristics and risks factors for development of dependence on hydrocodone and oxycodone.
2004 Jan-Feb
Office visits and analgesic prescriptions for musculoskeletal pain in US: 1980 vs. 2000.
2004 Jun
Hallucinations with zolpidem and fluoxetine in an impaired driver.
2004 Mar
CYP2D6 and CYP3A4 involvement in the primary oxidative metabolism of hydrocodone by human liver microsomes.
2004 Mar
[Gender and health in the daily press].
2004 May
[Origin and growth of the National Program of Continuous Academic Development for the General Physician].
2004 May-Jun
Presurgical intravenous parecoxib sodium and follow-up oral valdecoxib for pain management after laparoscopic cholecystectomy surgery reduces opioid requirements and opioid-related adverse effects.
2004 Oct
A 35-year-old physician with opioid dependence.
2004 Sep 15
Selective potentiation of opioid analgesia by nonsteroidal anti-inflammatory drugs.
2005 Apr 8
The GC-MS detection and characterization of neopine resulting from opium use and codeine metabolism and its potential as an opiate-product-use marker.
2005 Jun
A 46-year-old man with excruciating shoulder pain.
2005 Mar
Oral analgesics for acute nonspecific pain.
2005 Mar 1
Patents

Sample Use Guides

APADAZ Immediate-release tablets: 6.12 mg benzhydrocodone (equivalent to 6.67 mg benzhydrocodone hydrochloride) and 325 mg acetaminophen. Initiate treatment with APADAZ at 1 or 2 tablets every 4 to 6 hours as needed for pain. Dosage should not exceed 12 tablets in a 24­ hour period.
Route of Administration: Oral
Substance Class Chemical
Created
by admin
on Mon Mar 31 20:06:33 GMT 2025
Edited
by admin
on Mon Mar 31 20:06:33 GMT 2025
Record UNII
9GU1G05Y03
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
HYDROCODONE BITARTRATE ANHYDROUS
MI  
Common Name English
4,5.ALPHA.-EPOXY-3-METHOXY-17-METHYLMORPHINAN-6-ONE TARTRATE (1:1)
Preferred Name English
MORPHINAN-6-ONE, 4,5-EPOXY-3-METHOXY-17-METHYL-, (5.ALPHA.)-, (R-(R*,R*))-2,3-DIHYDROXYBUTANEDIOATE (1:1)
Common Name English
HYDROCODONE BITARTRATE, ANHYDROUS
Common Name English
HYDROCODONE BITARTRATE ANHYDROUS [MI]
Common Name English
Code System Code Type Description
FDA UNII
9GU1G05Y03
Created by admin on Mon Mar 31 20:06:33 GMT 2025 , Edited by admin on Mon Mar 31 20:06:33 GMT 2025
PRIMARY
CAS
143-71-5
Created by admin on Mon Mar 31 20:06:33 GMT 2025 , Edited by admin on Mon Mar 31 20:06:33 GMT 2025
PRIMARY
SMS_ID
100000091919
Created by admin on Mon Mar 31 20:06:33 GMT 2025 , Edited by admin on Mon Mar 31 20:06:33 GMT 2025
PRIMARY
EVMPD
SUB32412
Created by admin on Mon Mar 31 20:06:33 GMT 2025 , Edited by admin on Mon Mar 31 20:06:33 GMT 2025
PRIMARY
MERCK INDEX
m6093
Created by admin on Mon Mar 31 20:06:33 GMT 2025 , Edited by admin on Mon Mar 31 20:06:33 GMT 2025
PRIMARY
EPA CompTox
DTXSID40162277
Created by admin on Mon Mar 31 20:06:33 GMT 2025 , Edited by admin on Mon Mar 31 20:06:33 GMT 2025
PRIMARY
ECHA (EC/EINECS)
205-608-1
Created by admin on Mon Mar 31 20:06:33 GMT 2025 , Edited by admin on Mon Mar 31 20:06:33 GMT 2025
PRIMARY
PUBCHEM
5463977
Created by admin on Mon Mar 31 20:06:33 GMT 2025 , Edited by admin on Mon Mar 31 20:06:33 GMT 2025
PRIMARY
Related Record Type Details
PARENT -> SALT/SOLVATE
SUBSTANCE->BASIS OF STRENGTH
PARENT -> SALT/SOLVATE
SOLVATE->ANHYDROUS
Related Record Type Details
ACTIVE MOIETY