hydrocodone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	1386	125-29-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: hydrocodone dihydrocodeinone hydrocodon multacodin hydrocodone bitartrate hydrocodone polistirex	Narcotic analgesic related to CODEINE, but more potent and more addicting by weight. It is used also as cough suppressant. Molecular weight: 299.37 Formula: C18H21NO3 CLOGP: 1.13 LIPINSKI: 0 HAC: 4 HDO: 0 TPSA: 38.77 ALOGS: -2.57 ROTB: 1 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

hydrocodone
dihydrocodeinone
hydrocodon
multacodin
hydrocodone bitartrate
hydrocodone polistirex

Narcotic analgesic related to CODEINE, but more potent and more addicting by weight. It is used also as cough suppressant.

Molecular weight: 299.37
Formula: C18H21NO3
CLOGP: 1.13
LIPINSKI: 0
HAC: 4
HDO: 0
TPSA: 38.77
ALOGS: -2.57
ROTB: 1

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
15	mg	O

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	80 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
S (Water solubility)	62.50 mg/mL	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	2.15 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
EoM (Fraction excreted unchanged in urine)	10.20 %	Benet LZ, Broccatelli F, Oprea TI
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

Date	Agency	Company	Orphan
March 23, 1943	FDA	ENDO PHARMS

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Completed suicide	937.34	10.62	879	55677	144794	63287672
Cholecystitis chronic	465.18	10.62	213	56343	10148	63422318
Toxicity to various agents	392.97	10.62	751	55805	246499	63185967
Drug hypersensitivity	269.44	10.62	743	55813	309944	63122522
Cardio-respiratory arrest	254.55	10.62	290	56266	59669	63372797
Emotional distress	198.29	10.62	191	56365	32358	63400108
Cholelithiasis	178.88	10.62	208	56348	43717	63388749
Respiratory arrest	177.40	10.62	180	56376	32465	63400001
Contraindicated product administered	170.91	10.62	5	56551	217643	63214823
Drug abuse	166.98	10.62	260	56296	72258	63360208

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Completed suicide	509.70	12.10	532	31277	97636	34827486
Toxicity to various agents	294.99	12.10	596	31213	199766	34725356
Accidental overdose	225.13	12.10	169	31640	19971	34905151
Drug abuse	195.78	12.10	335	31474	98761	34826361
Cardio-respiratory arrest	189.06	12.10	242	31567	55031	34870091
Drug dependence	161.91	12.10	151	31658	24066	34901056
Respiratory arrest	139.68	12.10	149	31660	27894	34897228
Drug abuser	115.31	12.10	61	31748	3893	34921229
Off label use	106.34	12.10	136	31673	419388	34505734
Overdose	103.88	12.10	245	31564	90814	34834308

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Completed suicide	1718.07	10.87	1512	65466	244255	79433155
Toxicity to various agents	729.43	10.87	1283	65695	420257	79257153
Cardio-respiratory arrest	553.15	10.87	562	66416	107948	79569462
Cholecystitis chronic	425.52	10.87	194	66784	9712	79667698
Drug abuse	385.03	10.87	572	66406	162119	79515291
Respiratory arrest	343.24	10.87	325	66653	57225	79620185
Accidental overdose	266.01	10.87	239	66739	39342	79638068
Emotional distress	240.72	10.87	227	66751	39742	79637668
Intentional product misuse	205.65	10.87	321	66657	94844	79582566
Drug hypersensitivity	189.85	10.87	617	66361	298299	79379111

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	R05DA03	RESPIRATORY SYSTEM COUGH AND COLD PREPARATIONS COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS Opium alkaloids and derivatives
CHEBI has role	CHEBI:35482	narcotic analgesic
CHEBI has role	CHEBI:51177	anti-tussive
CHEBI has role	CHEBI:55322	mu-opioid agonists
FDA EPC	N0000175690	Opioid Agonist
FDA MoA	N0000000174	Opioid Agonists
MeSH PA	D000700	Analgesics
MeSH PA	D000701	Analgesics, Opioid
MeSH PA	D000996	Antitussive Agents
MeSH PA	D002491	Central Nervous System Agents

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Pain	indication	22253000
Cough	indication	49727002
Allergic rhinitis	indication	61582004
Nasal discharge	indication	64531003
Nasal congestion	indication	68235000
Rhinitis	indication	70076002	DOID:4483
Common cold	indication	82272006	DOID:10459
Brain damage	contraindication	2470005
Ocular hypertension	contraindication	4210003	DOID:9282
Tachyarrhythmia	contraindication	6285003

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.64	Basic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
100MG	HYSINGLA ER	PURDUE PHARMA LP	N206627	Nov. 20, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	10130591	Nov. 20, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
100MG	HYSINGLA ER	PURDUE PHARMA LP	N206627	Nov. 20, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	8309060	Nov. 20, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
100MG	HYSINGLA ER	PURDUE PHARMA LP	N206627	Nov. 20, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	11304909	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
100MG	HYSINGLA ER	PURDUE PHARMA LP	N206627	Nov. 20, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	9095614	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
100MG	HYSINGLA ER	PURDUE PHARMA LP	N206627	Nov. 20, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	9492390	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
100MG	HYSINGLA ER	PURDUE PHARMA LP	N206627	Nov. 20, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	9492391	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
100MG	HYSINGLA ER	PURDUE PHARMA LP	N206627	Nov. 20, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	9545380	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
100MG	HYSINGLA ER	PURDUE PHARMA LP	N206627	Nov. 20, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	8808740	Dec. 21, 2031	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG	ZOHYDRO ER	RECRO GAINESVILLE	N202880	Oct. 25, 2013	DISCN	CAPSULE, EXTENDED RELEASE	ORAL	10028946	July 25, 2033	TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
10MG	ZOHYDRO ER	RECRO GAINESVILLE	N202880	Oct. 25, 2013	DISCN	CAPSULE, EXTENDED RELEASE	ORAL	10456393	July 25, 2033	TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Mu-type opioid receptor	GPCR	P35372	OPRM_HUMAN	AGONIST	Ki	8.02		CHEMBL	CHEMBL
Kappa-type opioid receptor	GPCR	P41145	OPRK_HUMAN	AGONIST	Ki	6.59		CHEMBL

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External reference:

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ID	Source
001554	NDDF
001555	NDDF
001556	NDDF
13945	MMSL
142439	RXNORM
1700	INN_ID
20320002	SNOMEDCT_US
34195-34-1	SECONDARY_CAS_RN
372671002	SNOMEDCT_US
3874004	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Hydrocodone Bitartrate and Acetaminophen	HUMAN PRESCRIPTION DRUG LABEL	2	0121-0772	SOLUTION	7.50 mg	ORAL	ANDA	30 sections
Hydrocodone Bitartrate and Acetaminophen	HUMAN PRESCRIPTION DRUG LABEL	2	0121-0772	SOLUTION	7.50 mg	ORAL	ANDA	30 sections
Hydrocodone Bitartrate and Acetaminophen	HUMAN PRESCRIPTION DRUG LABEL	2	0121-0772	SOLUTION	7.50 mg	ORAL	ANDA	30 sections
Hydrocodone Bitartrate and Acetaminophen	HUMAN PRESCRIPTION DRUG LABEL	2	0121-1544	SOLUTION	5 mg	ORAL	ANDA	30 sections
Hydrocodone Bitartrate and Acetaminophen	HUMAN PRESCRIPTION DRUG LABEL	2	0121-1544	SOLUTION	5 mg	ORAL	ANDA	30 sections
Hydrocodone Bitartrate and Acetaminophen	HUMAN PRESCRIPTION DRUG LABEL	2	0121-1544	SOLUTION	5 mg	ORAL	ANDA	30 sections
Hydrocodone Bitartrate and Acetaminophen	HUMAN PRESCRIPTION DRUG LABEL	2	0121-2316	SOLUTION	7.50 mg	ORAL	ANDA	30 sections
Hydrocodone Bitartrate and Acetaminophen	HUMAN PRESCRIPTION DRUG LABEL	2	0121-2316	SOLUTION	7.50 mg	ORAL	ANDA	30 sections
Hydrocodone Bitartrate and Acetaminophen	HUMAN PRESCRIPTION DRUG LABEL	2	0121-2316	SOLUTION	7.50 mg	ORAL	ANDA	30 sections
Hydrocodone Bitartrate and Acetaminophen	HUMAN PRESCRIPTION DRUG LABEL	2	0121-4772	SOLUTION	2.50 mg	ORAL	ANDA	30 sections

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