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Drug ReportsHydrocodone
Hydrocodone
/ Hydrocodone, / Hydrocodone /, Anexsia, Codamine, Flowtuss, Hycodan, Hycofenix, Hydrocodone, Hydrocodone /, Hysingla, Obredon, Rezira, Vituz, Xtrelus (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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Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Hydrocodone, Hysingla (discontinued: Hysingla, Vantrela, Zohydro)
Combinations
Anexsia, Hycodan, Hydrocodone acetaminophen, Hydrocodone aspirin, Hydrocodone bitartrate, chlorpheniramine pseudoephedrine, Hydrocodone homatropine methylbromide, Hydrocodone ibuprofen, Hydrocodone polistirex chlorpheniramine polistirex, Reprexain (discontinued: Acetaminophen hydrocodone, Allay, Anexsia, Azdone, Bancap, Co-gesic, Codamine, Duradyne dhc, Flowtuss, Homatropine methylbromide hydrocodone, Hycofenix, Hydrocodone, Hydrocodone acetaminophen, Hydrocodone bitartrate, chlorpheniramine pseudoephedrine, Hydrocodone chlorpheniramine, Hydrocodone homatropine methylbromide, Hydrocodone ibuprofen, Hydrocodone polistirex chlorpheniramne polistirex, Hydrocodone pseudoephedrine, Hydropane, Lorcet-hd, Lortab, Norco, Obredon, Reprexain, Rezira, Tussigon, Tussionex pennkinetic, Tycolet, Vicodin, Vicoprin, Vicoprofen, Vituz, Xtrelus, Zutripro, Zydone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Hydrocodone bitartrate
Tradename
Company
Number
Date
Products
HYSINGLA ERPurdue PharmaN-206627 RX2014-11-20
6 products, RLD
Show 3 discontinued
Hydrocodone bitartrate
+
Ibuprofen
Tradename
Company
Number
Date
Products
VICOPROFENAbbVieN-020716 DISCN1997-09-23
1 products, RLD
Hide discontinued
Homatropine methylbromide
+
Hydrocodone bitartrate
Tradename
Company
Number
Date
Products
HYCODANGenus LifesciencesN-005213 RX1988-07-26
2 products, RLD
Guaifenesin
+
Hydrocodone bitartrate
Tradename
Company
Number
Date
Products
FLOWTUSSChartwell PharmaceuticalsN-022424 DISCN2015-05-14
1 products
XTRELUSECI PharmaceuticalsN-208085 DISCN2018-04-25
1 products, RLD
OBREDONSovereign PharmaceuticalsN-205474 DISCN2014-11-14
1 products, RLD
Hide discontinued
Guaifenesin
+
Hydrocodone bitartrate
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
HYCOFENIXChartwell PharmaceuticalsN-022279 DISCN2015-05-14
1 products, RLD
Hide discontinued
Hydrocodone bitartrate
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
REZIRAPersion PharmaceuticalsN-022442 DISCN2011-06-08
1 products, RLD
Hide discontinued
Chlorpheniramine maleate
+
Hydrocodone bitartrate
Tradename
Company
Number
Date
Products
VITUZPersion PharmaceuticalsN-204307 DISCN2013-02-20
1 products, RLD
Hide discontinued
Chlorpheniramine maleate
+
Hydrocodone bitartrate
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
ZUTRIPROPersion PharmaceuticalsN-022439 DISCN2011-06-08
1 products, RLD
Hide discontinued
Chlorpheniramine polistirex
+
Hydrocodone polistirex
Tradename
Company
Number
Date
Products
TUSSIONEX PENNKINETICUCBN-019111 DISCN1987-12-31
1 products, RLD
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
hycodanNew Drug Application2024-01-09
hydrocodone /apapANDA2022-10-05
hydrocodone acetaminophenANDA2011-05-24
hydrocodone apapANDA2025-01-28
hydrocodone bit/apapANDA2015-08-24
hydrocodone bitartate and acetaminophenANDA2018-09-26
hydrocodone bitartrateANDA2024-01-01
hydrocodone bitartrate and acetaminophenANDA2025-09-10
hydrocodone bitartrate and acetaminophen tabletsANDA2011-12-15
hydrocodone bitartrate and aspirinANDA2024-03-27
Show 25 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
painEFO_0003843D010146R52
fever—D005334R50.9
postoperative pain—D010149G89.18
obstructive lung diseases—D008173—
cough—D003371R05
inflammationMP_0001845D007249—
juvenile arthritisEFO_1002007D001171M08
menorrhagiaEFO_0003945D008595N92.0
ankylosing spondylitisEFO_0003898D013167M45
rheumatoid arthritisEFO_0000685D001172M06.9
Show 18 more
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Guaifenesin / Hydrocodone Bitartrate, Obredon, Sovereign Pharms
95499072035-11-13DS, DPU-2023
98084312035-11-13DS, DPU-2023
101053242035-11-13DS, DPU-2023
Hydrocodone Bitartrate, Zohydro Er, Recro Gainesville
91320962034-09-12DP
94521632034-09-12U-55
94864512034-09-12U-55
97136112034-09-12DPU-55
100925592034-09-12U-55
92657602033-07-25U-1810
93269822033-07-25U-1810
93332012033-07-25U-1810
93394992033-07-25U-1810
94212002033-07-25U-1810
94336192033-07-25U-1810
96102862033-07-25U-1810
100289462033-07-25U-1810
103221202033-07-25DP
104563932033-07-25U-1810
107225112033-07-25U-1810
Hydrocodone Bitartrate, Hysingla Er, Purdue Pharma Lp
88087402031-12-21DPU-1556
95727792031-12-21DP
97507032031-12-21DP
98615842031-12-21DP
98728372031-12-21DP
90848162027-08-24DP
90956142027-08-24U-1556
90956152027-08-24DP
94864122027-08-24DP
94864132027-08-24DP
94923892027-08-24DP
94923902027-08-24U-1556
94923912027-08-24U-1556
95453802027-08-24U-1556
97639332027-08-24DP
97704162027-08-24DP
97758092027-08-24DP
113049082027-08-24DP
113049092027-08-24U-1556
118448652025-02-13DPU-1556
Hydrocodone Bitartrate, Vantrela Er, Teva Branded Pharm
84450182029-07-31DP
92161762027-09-13DP
95728032027-09-13DP
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
179 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PainD010146EFO_0003843R5249109638
Postoperative painD010149—G89.1854811431
Low back painD017116—M54.5—291214
Back painD001416—M54—291113
Chronic painD059350———252312
VomitingD014839—R11.1——4138
NauseaD009325—R11.0——4138
OsteoarthritisD010003EFO_0002506M15-M19—23218
Pain managementD059408—————426
Rotator cuff injuriesD000070636—M75.1—1—225
Show 49 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acute painD059787—R52476—118
Shoulder painD020069—M25.51——2—13
Neoplasm metastasisD009362EFO_0009708—1—1——2
Anterior cruciate ligament injuriesD000070598———11——1
Multiple myelomaD009101—C90.0——1——1
LymphomaD008223—C85.9——1——1
HerniaD006547—K40-K46——1——1
Head and neck neoplasmsD006258————1——1
MucositisD052016EFO_1001898———1——1
Radiation-induced abnormalitiesD000016EFO_0009565L57——1——1
Show 5 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Opioid-related disordersD009293EFO_0005611F1122——26
Musculoskeletal painD059352——11———2
Corneal injuriesD065306———1———1
Eye injuriesD005131—S00-S09—1———1
Back injuriesD019567———1———1
Abdominal neoplasmsD000008———1———1
Ankle injuriesD016512—S93.4—1———1
Tendon injuriesD013708———1———1
Foot injuriesD018409———1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———14————14
Drug interactionsD004347——1———23
Substance-related disordersD019966EFO_0003890F131———23
Renal insufficiencyD051437—N192————2
Liver diseasesD008107EFO_0001421K70-K772————2
Hepatic insufficiencyD048550——2————2
Thyroid diseasesD013959—E00-E071————1
Parathyroid diseasesD010279—E21.51————1
Hematologic neoplasmsD019337——1————1
Ankle fracturesD064386—S82.51————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cancer painD000072716—G89.3————22
Personality disordersD010554—F60.6————22
Breast neoplasmsD001943EFO_0003869C50————11
Intractable painD010148——————11
Femoracetabular impingementD057925——————11
ThyroidectomyD013965——————11
Rotator cuff tear arthropathyD000070656——————11
ContraceptionD003267——————11
Respiratory aspirationD053120EFO_1001839—————11
Soft tissue injuriesD017695——————11
Show 12 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameHydrocodone
INNhydrocodone
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 classOpioid
Image (chem structure or protein)Loading
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-ID125-29-1
RxCUI—
ChEMBL IDCHEMBL1457
ChEBI ID5779
PubChem CID5284569
DrugBankDB00956
UNII ID6YKS4Y3WQ7 (ChemIDplus, GSRS)
Target
Agency Approved
OPRM1
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 (Q9R1M0)
Alternate
OPRK1
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
No data
Financial
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Hydrocodone
+
Acetaminophen
Total medical expenditures per year (USD, in millions)
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Hydrocodone
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Aspirin
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Hydrocodone
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Phenylephrine
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Brompheniramine
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Hydrocodone
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Phenylephrine
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Carbinoxamine
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Hydrocodone
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Chlorpheniramine
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Chlorpheniramine
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Hydrocodone
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Phenylephrine
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Dexbrompheniramine
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Hydrocodone
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Phenylephrine
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Dexchlorpheniramine
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Hydrocodone
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Diphenhydramine
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Hydrocodone
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Guaifenesin
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Guaifenesin
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Hydrocodone
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Homatropine
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Hydrocodone
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Hydrocodone
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Ibuprofen
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Phenylephrine
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Hydrocodone
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Phenylephrine
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Pyrilamine
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Hydrocodone
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Phenylpropanolamine
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,718 documents
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Safety
Black-box Warning
Black-box warning for: Hycodan, Hydrocodone /apap, Hydrocodone bit/apap, Hydrocodone bitartate and acetaminophen, Hydrocodone bitartrate, Hydrocodone bitartrate and acetaminophen, Hydrocodone bitartrate and aspirin, Hydrocodone bitartrate and homatropine methylbromide, Hydrocodone bitartrate and ibuprofen, Hydrocodone polistirex and chlorpheniramine polistirex, Hydrocodone/apap, Hydromet, Hysingla er, Lortab, Norco, Obredon, Zohydro
Adverse Events
Top Adverse Reactions
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143,537 adverse events reported
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