Hydrocodone

Allay, Anexsia, Azdone, Bancap, Co-gesic, Codamine, Duradyne Dhc, Flowtuss, Hy-phen, Hycodan, Hycofenix, Hysingla, Lorcet-hd, Lortab, Norcet, Norco, Obredon, Reprexain, Rezira, Tycolet, Vicodin, Vicoprin, Vicoprofen, Vituz, Xtrelus, Zutripro, Zydone, Zyfrel (hydrocodone) is a small molecule pharmaceutical. Hydrocodone was first approved as Vicodin on 1982-01-01. It is used to treat cough, obstructive lung diseases, and postoperative pain in the USA. The pharmaceutical is active against mu-type opioid receptor. In addition, it is known to target kappa-type opioid receptor.

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Therapeutic Areas

Therapeutic Area	MeSH
respiratory tract diseases	D012140
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Hysingla (generic drugs available since 1983-03-03, discontinued: Vantrela, Zohydro)

Combinations

Hycodan (generic drugs available since 1983-03-03, discontinued: Allay, Anexsia, Azdone, Bancap, Co-gesic, Codamine, Duradyne dhc, Flowtuss, Hy-phen, Hycofenix, Hydropane, Lorcet-hd, Lortab, Norcet, Norco, Obredon, Reprexain, Rezira, Tussigon, Tycolet, Vicodin, Vicoprin, Vicoprofen, Vituz, Xtrelus, Zutripro, Zydone, Zyfrel)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Chlorpheniramine maleate

Hydrocodone bitartrate

Tradename	Company	Number	Date	Products
VITUZ	Persion Pharmaceuticals	N-204307 DISCN	2013-02-20	1 products, RLD

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Chlorpheniramine maleate

Hydrocodone bitartrate

Pseudoephedrine hydrochloride

Tradename	Company	Number	Date	Products
ZUTRIPRO	Persion Pharmaceuticals	N-022439 DISCN	2011-06-08	1 products, RLD

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Guaifenesin

Hydrocodone bitartrate

Tradename	Company	Number	Date	Products
FLOWTUSS	Chartwell Pharmaceuticals	N-022424 DISCN	2015-05-14	1 products
XTRELUS	ECI Pharmaceuticals	N-208085 DISCN	2018-04-25	1 products, RLD
OBREDON	Sovereign Pharmaceuticals	N-205474 DISCN	2014-11-14	1 products, RLD

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Guaifenesin

Hydrocodone bitartrate

Pseudoephedrine hydrochloride

Tradename	Company	Number	Date	Products
HYCOFENIX	Chartwell Pharmaceuticals	N-022279 DISCN	2015-05-14	1 products, RLD

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Homatropine methylbromide

Hydrocodone bitartrate

Tradename	Company	Number	Date	Products
HYCODAN	Genus Lifesciences	N-005213 RX	1988-07-26	2 products, RLD

Hydrocodone bitartrate

Tradename	Company	Number	Date	Products
HYSINGLA ER	Purdue Pharma	N-206627 RX	2014-11-20	7 products, RLD

Show 2 discontinued

Hydrocodone bitartrate

Ibuprofen

Tradename	Company	Number	Date	Products
VICOPROFEN	AbbVie	N-020716 DISCN	1997-09-23	1 products, RLD

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Hydrocodone bitartrate

Pseudoephedrine hydrochloride

Tradename	Company	Number	Date	Products
REZIRA	Persion Pharmaceuticals	N-022442 DISCN	2011-06-08	1 products, RLD

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Labels

FDA

EMA

Brand Name	Status	Last Update
hycodan	New Drug Application	2021-12-29
hydrocodone bitartrate and acetaminophen	ANDA	2023-06-12
hysingla er	New Drug Application	2021-03-01
lortab	ANDA	2022-01-28
norco	ANDA	2023-03-20
obredon	New Drug Application	2021-09-30
reprexain	ANDA	2009-10-27
vicoprofen	New Drug Application	2011-08-12
zohydro	New Drug Application	2015-02-25
zydone	ANDA	2010-07-13

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
cough	HP_0012735	D003371	R05
obstructive lung diseases	HP_0006536	D008173	—
postoperative pain	—	D010149	G89.18

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag	FDA Information
Guaifenesin / Hydrocodone Bitartrate, Obredon, Sovereign Pharms
9549907	2035-11-13	DS, DP	U-2023
9808431	2035-11-13	DS, DP	U-2023
10105324	2035-11-13	DS, DP	U-2023
Hydrocodone Bitartrate, Zohydro Er, Recro Gainesville
9132096	2034-09-12	DP
9452163	2034-09-12		U-55
9486451	2034-09-12		U-55
9713611	2034-09-12	DP	U-55
10092559	2034-09-12		U-55
9265760	2033-07-25		U-1810
9326982	2033-07-25		U-1810
9333201	2033-07-25		U-1810
9339499	2033-07-25		U-1810
9421200	2033-07-25		U-1810
9433619	2033-07-25		U-1810
9610286	2033-07-25		U-1810
10028946	2033-07-25		U-1810
10322120	2033-07-25	DP
10456393	2033-07-25		U-1810
10722511	2033-07-25		U-1810
Hydrocodone Bitartrate, Hysingla Er, Purdue Pharma Lp
8808740	2031-12-21	DP	U-1556
9572779	2031-12-21	DP
9750703	2031-12-21	DP
9861584	2031-12-21	DP
9872837	2031-12-21	DP
9084816	2027-08-24	DP
9095614	2027-08-24		U-1556
9095615	2027-08-24	DP
9486412	2027-08-24	DP
9486413	2027-08-24	DP
9492389	2027-08-24	DP
9492390	2027-08-24		U-1556
9492391	2027-08-24		U-1556
9545380	2027-08-24		U-1556
9763933	2027-08-24	DP
9770416	2027-08-24	DP
9775809	2027-08-24	DP
11304908	2027-08-24	DP
11304909	2027-08-24		U-1556
8309060	2023-11-20	DP	U-1556
10130591	2023-11-20	DP	U-1819
9675610	2023-06-16	DP
10369109	2023-06-16	DP
Hydrocodone Bitartrate, Vantrela Er, Teva Branded Pharm
8445018	2029-07-31	DP
9216176	2027-09-13	DP
9572803	2027-09-13	DP

ATC Codes

R: Respiratory system drugs

— R05: Cough and cold preparations

— R05D: Cough suppressants, excl. combinations with expectorants

— R05DA: Opium alkaloids and derivatives, cough suppressants

— R05DA03: Hydrocodone

HCPCS

No data

Clinical

Clinical Trials

129 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pain	D010146	EFO_0003843	R52	4	7	6	6	2	25
Postoperative pain	D010149		G89.18	2	2	6	9	2	21
Chronic pain	D059350	HP_0012532		—	—	3	2	—	5
Acute pain	D059787		R52	2	—	—	1	1	4
Nausea	D009325	HP_0002018	R11.0	—	—	2	1	—	3
Postoperative nausea and vomiting	D020250	EFO_0004888		—	—	—	1	1	2
Rotator cuff injuries	D000070636		M75.1	—	1	—	1	—	2
Pain management	D059408			—	—	—	2	—	2
Constipation	D003248	HP_0002019	K59.0	—	—	—	2	—	2
Toothache	D014098		K08.89	—	—	—	1	1	2

Show 29 more

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Low back pain	D017116	HP_0003419	M54.5	—	1	4	—	1	6
Osteoarthritis	D010003	EFO_0002506	M15-M19	—	1	1	—	—	2
Anterior cruciate ligament injuries	D000070598			—	1	2	—	—	2
Shoulder pain	D020069	HP_0030834	M25.51	—	—	1	—	1	2
Head and neck neoplasms	D006258			1	—	1	—	—	2
Vomiting	D014839	HP_0002013	R11.1	—	—	2	—	—	2
Postoperative complications	D011183			—	—	1	—	—	1
Tibial meniscus injuries	D000070600			—	—	1	—	—	1
Multiple myeloma	D009101		C90.0	—	—	1	—	—	1
Lymphoma	D008223		C85.9	—	—	1	—	—	1

Show 8 more

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Musculoskeletal pain	D059352			1	1	—	—	—	2
Corneal injuries	D065306	HP_0000559		—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—			7	—	—	—	—	7
Drug interactions	D004347			1	—	—	—	1	2
Opioid-related disorders	D009293	EFO_0005611	F11	2	—	—	—	—	2
Intervertebral disc degeneration	D055959	HP_0008419		1	—	—	—	—	1
Spondylolisthesis	D013168	EFO_0007493	M43.1	1	—	—	—	—	1
Ankle fractures	D064386		S82.5	1	—	—	—	—	1
Stomatitis	D013280	EFO_1001904	K12.1	1	—	—	—	—	1
Substance-related disorders	D019966	EFO_0003890	F13	1	—	—	—	—	1
Hepatic insufficiency	D048550			1	—	—	—	—	1
Renal insufficiency	D051437	HP_0000083	N19	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hip fractures	D006620	EFO_0003964	S72.00	—	—	—	—	1	1
Anesthesia	D000758			—	—	—	—	1	1
Breast neoplasms	D001943	EFO_0003869	C50	—	—	—	—	1	1
Thyroidectomy	D013965			—	—	—	—	1	1
Soft tissue injuries	D017695			—	—	—	—	1	1
Lacerations	D022125			—	—	—	—	1	1
Methods	D008722			—	—	—	—	1	1
Tooth migration	D014085			—	—	—	—	1	1
Dysmenorrhea	D004412	HP_0100607	N94.6	—	—	—	—	1	1
Sleep	D012890	GO_0030431		—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	HYDROCODONE
INN	hydrocodone
Description	Hydrocodone is a morphinane-like compound that is a semi-synthetic opioid synthesized from codeine. It has a role as a mu-opioid receptor agonist, an opioid analgesic and an antitussive. It is an organic heteropentacyclic compound and a morphinane-like compound. It derives from a hydride of a morphinan.
Classification	Small molecule
Drug class	—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	COc1ccc2c3c1O[C@H]1C(=O)CC[C@H]4[C@@H](C2)N(C)CC[C@]314

Identifiers

PDB	—
CAS-ID	125-29-1
RxCUI	5489
ChEMBL ID	CHEMBL1457
ChEBI ID	5779
PubChem CID	5284569
DrugBank	DB00956
UNII ID	6YKS4Y3WQ7 (ChemIDplus, GSRS)

Target

Agency Approved

OPRM1

Organism

Homo sapiens

Gene name

OPRM1

Gene synonyms

MOR1

NCBI Gene ID

4988

Protein name

mu-type opioid receptor

Protein synonyms

hMOP, MOP, Mu opiate receptor, Mu opioid receptor, mu opioid receptor hMOR-1a

Uniprot ID

Q9UN57

Mouse ortholog

Oprm1 (18390)

mu-type opioid receptor (P42866)

Alternate

OPRK1

Organism

Homo sapiens

Gene name

OPRK1

Gene synonyms

OPRK

NCBI Gene ID

4986

Protein name

kappa-type opioid receptor

Protein synonyms

kappa opioid receptor, Opiate receptor, kappa-1

Uniprot ID

Q499G4

Mouse ortholog

Oprk1 (18387)

kappa-type opioid receptor (P33534)

Variants

Clinical Variant

No data

Financial

No data

Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Additional graphs summarizing 15,805 documents

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Safety

Black-box Warning

Black-box warning for: Hycodan, Hydrocodone bitartrate and acetaminophen, Hysingla er, Lortab, Norco, Obredon, Zohydro

Adverse Events

Top Adverse Reactions

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83,315 adverse events reported

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Companies, Drugs, and Diseases

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