PharmaKB logo
Company Reports
Company Reports
Drug Reports
Drug Reports
Disease Reports
Disease Reports
Sets
Sets
Favorites
Favorites
Log in
Log in
AboutPricing
Drug ReportsCodeine
Codeine
/ Butalbital / Caffeine / Codeine, Acetaminophen / Butalbital / Caffeine / Codeine, Acetaminophen / Codeine, Ambenyl, Bromanyl, Codeine, Codeine / / Promethazine, Codeine / Promethazine, Fioricet, Soma, Triacin-c, Tuxarin (codeine) is a small molecule pharmaceutical. Codeine was first approved as Codeine, aspirin, apap formula no. 4 on 1982-01-01. It is used to treat cough and pain in the USA. The pharmaceutical is active against mu-type opioid receptor.
Download report
Favorite
Searched
Events Timeline
Commercial
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
Start date
Primary completion date
Completion date
Results first post date
Plot placeholder
Mock data
Subscribe for the real data
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
signs and symptoms pathological conditionsD013568
psychological phenomenaD011579
musculoskeletal and neural physiological phenomenaD055687
Trade Name
FDA
EMA
Codeine (discontinued: Codeine)
Combinations
Acetaminophen codeine, Butalbital, acetaminophen, caffeine codeine, Butalbital, aspirin, caffeine, codeine, Fioricet, Prometh hydrochloride,phenylephrine w/codeine, Promethazine codeine, Promethazine hydrochloride,phenylephrine w/codeine, Tuxarin (discontinued: Acetaminophen codeine, Actifed, Ambenyl, Bromanyl, Bromodiphenhydramine codeine, Butalbital, acetaminophen, caffeine codeine, Butalbital, aspirin, caffeine, codeine, Capital codeine, Carisoprodol, aspirin codeine, Codeine, aspirin, apap no., Codeprex, Codrix, Empracet, Fiorinal w/codeine, Penntuss, Phenaphen, Phenergan, Pherazine, Phrenilin with caffeine codeine, Prometh, Promethazine, Promethazine codeine, Promethazine hydrochloride, phenylephrine w/codeine, Promethazine with codeine, Proval, Soma, Triprolidine hydrochloride, pseudoephedrine codeine, Tuzistra, Tylenol)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Codeine phosphate
+
Pseudoephedrine hydrochloride
+
Triprolidine hydrochloride
Tradename
Company
Number
Date
Products
ACTIFED W/ CODEINEGSKN-012575 DISCN1984-04-04
1 products
Hide discontinued
Aspirin
+
Butalbital
+
Caffeine
+
Codeine phosphate
Tradename
Company
Number
Date
Products
FIORINAL W/CODEINEAllerganN-019429 DISCN1990-10-26
1 products, RLD
Hide discontinued
Codeine phosphate
+
Promethazine hydrochloride
Tradename
Company
Number
Date
Products
PHENERGAN W/ CODEINEANI PharmaceuticalsN-008306 DISCN1984-04-02
1 products, RLD
Hide discontinued
Codeine phosphate
+
Phenylephrine hydrochloride
+
Promethazine hydrochloride
Tradename
Company
Number
Date
Products
PHENERGAN VC W/ CODEINEANI PharmaceuticalsN-008306 DISCN1984-04-02
1 products, RLD
Hide discontinued
Bromodiphenhydramine hydrochloride
+
Codeine phosphate
Tradename
Company
Number
Date
Products
AMBENYLForest LaboratoriesN-009319 DISCN1984-01-10
1 products
Hide discontinued
Codeine sulfate
Tradename
Company
Number
Date
Products
CODEINE SULFATEHikma PharmaceuticalsN-022402 RX2009-07-16
3 products, RLD, RS
Show 1 discontinued
Aspirin
+
Carisoprodol
+
Codeine phosphate
Tradename
Company
Number
Date
Products
SOMA COMPOUND W/ CODEINEMeda ABN-012366 DISCN1983-07-11
1 products
Hide discontinued
Chlorpheniramine maleate
+
Codeine phosphate
Tradename
Company
Number
Date
Products
TUXARIN ERMainPointe PharmaceuticalsN-206323 RX2015-06-22
1 products
Acetaminophen
+
Butalbital
+
Caffeine
+
Codeine phosphate
Tradename
Company
Number
Date
Products
FIORICET W/ CODEINEAllerganN-020232 RX1992-07-30
1 products, RLD, RS
Chlorpheniramine polistirex
+
Codeine polistirex
Tradename
Company
Number
Date
Products
PENNTUSSFisonsN-018928 DISCN1985-08-14
1 products
CODEPREXLannettN-021369 DISCN2004-06-21
1 products
TUZISTRA XRTris PharmaN-207768 DISCN2015-04-30
1 products, RLD
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
acetaminophen and codeineANDA2025-04-29
acetaminophen and codeine phosphateANDA2025-10-28
acetaminophen with codeineANDA2015-01-11
ascomp with codeineANDA2024-11-19
butalbital, acetaminophen, caffeine and codeine phosphateANDA2025-03-14
butalbital, acetaminophen, caffeine, and codeine phosphateNDA authorized generic2024-02-29
butalbital, aspirin, caffeine and codeine phosphateANDA2024-07-19
cheratussin acOTC monograph final2019-01-24
codarOTC monograph final2011-07-26
codeine and chlorpheniramine maleate erNew Drug Application2017-01-20
Show 76 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
painEFO_0003843D010146R52
fever—D005334R50.9
cough—D003371R05
myositisEFO_0000783D009220G72.49
rheumatoid arthritisEFO_0000685D001172M06.9
inflammationMP_0001845D007249—
osteoarthritisEFO_0002506D010003M15-M19
muscle spasticity—D009128—
muscle cramp—D009120—
spasm—D013035M62.83
Show 31 more
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Chlorpheniramine Maleate / Codeine Phosphate, Tuxarin Er, Mainpointe
90669422032-01-03U-1716
91079212032-01-03DP
ATC Codes
N: Nervous system drugs
— N02: Analgesics
— N02A: Opioid analgesics
— N02AA: Natural opium alkaloid analgesics
— N02AA59: Codeine, combinations excl. psycholeptics
— N02AA79: Codeine, combinations with psycholeptics
— N02AJ: Opioids in combination with non-opioid analgesics
— N02AJ06: Codeine and paracetamol
— N02AJ07: Codeine and acetylsalicylic acid
— N02AJ08: Codeine and ibuprofen
— N02AJ09: Codeine and other non-opioid analgesics
R: Respiratory system drugs
— R05: Cough and cold preparations
— R05D: Cough suppressants, excl. combinations with expectorants
— R05DA: Opium alkaloids and derivatives, cough suppressants
— R05DA04: Codeine
HCPCS
Code
Description
J0745
Injection, codeine phosphate, per 30 mg
Clinical
Clinical Trials
546 clinical trials
View more details
Plot placeholder
Mock data
Subscribe for the real data
Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PainD010146EFO_0003843R521612302121100
Postoperative painD010149—G89.1837244620100
Healthy volunteers/patients———401—2345
Chronic painD059350——4168524
Opioid-related disordersD009293EFO_0005611F118714424
OsteoarthritisD010003EFO_0002506M15-M191658323
Acute painD059787—R525554423
Low back painD017116—M54.512104421
Cancer painD000072716—G89.3—368219
Back painD001416—M54—2113319
Show 142 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AnesthesiaD000758———11—34
HypertensionD006973EFO_0000537I10—11—23
SyndromeD013577————2—13
Neoplasm metastasisD009362EFO_0009708—1—1—13
Nociceptive painD059226————1—12
Intractable painD010148————1—12
Multiple myelomaD009101—C90.0——1—12
LymphomaD008223—C85.9——1—12
Neck painD019547—M54.2—11——2
MyopiaD009216EFO_0003927H52.1—11——2
Show 25 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Drug interactionsD004347——11——23
AdenoidectomyD000233——22———2
Corneal injuriesD065306——11———2
Ataxia telangiectasiaD001260Orphanet_100G11.3—1———1
Dental pinsD003772———1———1
Heroin dependenceD006556EFO_0004240——1———1
TonsillectomyD014068———1———1
Pre-eclampsiaD011225EFO_0000668O14—1———1
Spinal cord injuriesD013119EFO_1001919——1———1
Multiple traumaD009104—T07—1———1
Show 22 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypercapniaD006935——3————3
Narcotic-related disordersD000079524——1———12
Obstetric labor complicationsD007744——1———12
Squamous cell carcinoma of head and neckD000077195——1———12
Depressive disorderD003866EFO_1002014F32.A2————2
Recreational drug useD000084783——2————2
Colorectal neoplasmsD015179——1————1
Peritoneal neoplasmsD010534——1————1
Addictive behaviorD016739EFO_0004347—1————1
Replacement arthroplasty kneeD019645——1————1
Show 16 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Heart failureD006333EFO_0003144I50————33
HeadacheD006261—R51————33
InfectionsD007239EFO_0000544—————22
MenorrhagiaD008595EFO_0003945N92.0————22
Hemophilia aD006467EFO_0007267D66————22
PneumoniaD011014EFO_0003106J18————22
HyperaldosteronismD006929—E26————22
Pulmonary arterial hypertensionD000081029——————22
Urinary tract infectionsD014552EFO_0003103N39.0————22
EdemaD004487—R60.9————22
Show 148 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
Drug common nameCodeine
INNparacetamol
Description
Codeine is a morphinane alkaloid found in the opium poppy, Papaver somniferum var. album; has analgesic, anti-tussive and anti-diarrhoeal properties. It has a role as an opioid analgesic, an antitussive, an opioid receptor agonist, a prodrug, a xenobiotic, an environmental contaminant and a drug allergen. It is an organic heteropentacyclic compound and a morphinane alkaloid. It is functionally related to a morphine. It is a conjugate base of a codeine(1+).
Classification
Small molecule
Drug classOpioidAntitussives
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COc1ccc2c3c1O[C@H]1[C@@H](O)C=C[C@H]4[C@@H](C2)N(C)CC[C@]314
Identifiers
PDB—
CAS-ID76-57-3
RxCUI—
ChEMBL IDCHEMBL485
ChEBI ID16714
PubChem CID5284371
DrugBankDB00318
UNII ID362O9ITL9D (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
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Codeine
+
Acetaminophen
Total medical expenditures per year (USD, in millions)
Plot placeholder
Mock data
Subscribe for the real data
Number of persons purchased
Plot placeholder
Mock data
Subscribe for the real data
Number of purchases
Plot placeholder
Mock data
Subscribe for the real data
Refill frequency
Plot placeholder
Mock data
Subscribe for the real data
Price per prescription (USD)
Plot placeholder
Mock data
Subscribe for the real data
Codeine
+
Aspirin
+
Carisoprodol
Total medical expenditures per year (USD, in millions)
Plot placeholder
Mock data
Subscribe for the real data
Number of persons purchased
Plot placeholder
Mock data
Subscribe for the real data
Number of purchases
Plot placeholder
Mock data
Subscribe for the real data
Refill frequency
Plot placeholder
Mock data
Subscribe for the real data
Price per prescription (USD)
Plot placeholder
Mock data
Subscribe for the real data
Codeine
+
Aspirin
Total medical expenditures per year (USD, in millions)
Plot placeholder
Mock data
Subscribe for the real data
Number of persons purchased
Plot placeholder
Mock data
Subscribe for the real data
Number of purchases
Plot placeholder
Mock data
Subscribe for the real data
Refill frequency
Plot placeholder
Mock data
Subscribe for the real data
Price per prescription (USD)
Plot placeholder
Mock data
Subscribe for the real data
Codeine
+
Bromodiphenhydramine
Total medical expenditures per year (USD, in millions)
Plot placeholder
Mock data
Subscribe for the real data
Number of persons purchased
Plot placeholder
Mock data
Subscribe for the real data
Number of purchases
Plot placeholder
Mock data
Subscribe for the real data
Refill frequency
Plot placeholder
Mock data
Subscribe for the real data
Price per prescription (USD)
Plot placeholder
Mock data
Subscribe for the real data
Codeine
+
Phenylephrine
+
Brompheniramine
Total medical expenditures per year (USD, in millions)
Plot placeholder
Mock data
Subscribe for the real data
Number of persons purchased
Plot placeholder
Mock data
Subscribe for the real data
Number of purchases
Plot placeholder
Mock data
Subscribe for the real data
Refill frequency
Plot placeholder
Mock data
Subscribe for the real data
Price per prescription (USD)
Plot placeholder
Mock data
Subscribe for the real data
Codeine
+
Brompheniramine
+
Phenylpropanolamine
Total medical expenditures per year (USD, in millions)
Plot placeholder
Mock data
Subscribe for the real data
Number of persons purchased
Plot placeholder
Mock data
Subscribe for the real data
Number of purchases
Plot placeholder
Mock data
Subscribe for the real data
Refill frequency
Plot placeholder
Mock data
Subscribe for the real data
Price per prescription (USD)
Plot placeholder
Mock data
Subscribe for the real data
Codeine
+
Phenylephrine
+
Chlorpheniramine
Total medical expenditures per year (USD, in millions)
Plot placeholder
Mock data
Subscribe for the real data
Number of persons purchased
Plot placeholder
Mock data
Subscribe for the real data
Number of purchases
Plot placeholder
Mock data
Subscribe for the real data
Refill frequency
Plot placeholder
Mock data
Subscribe for the real data
Price per prescription (USD)
Plot placeholder
Mock data
Subscribe for the real data
Codeine
Total medical expenditures per year (USD, in millions)
Plot placeholder
Mock data
Subscribe for the real data
Number of persons purchased
Plot placeholder
Mock data
Subscribe for the real data
Number of purchases
Plot placeholder
Mock data
Subscribe for the real data
Refill frequency
Plot placeholder
Mock data
Subscribe for the real data
Price per prescription (USD)
Plot placeholder
Mock data
Subscribe for the real data
Codeine
+
Phenylephrine
+
Diphenhydramine
Total medical expenditures per year (USD, in millions)
Plot placeholder
Mock data
Subscribe for the real data
Number of persons purchased
Plot placeholder
Mock data
Subscribe for the real data
Number of purchases
Plot placeholder
Mock data
Subscribe for the real data
Refill frequency
Plot placeholder
Mock data
Subscribe for the real data
Price per prescription (USD)
Plot placeholder
Mock data
Subscribe for the real data
Codeine
+
Guaifenesin
Total medical expenditures per year (USD, in millions)
Plot placeholder
Mock data
Subscribe for the real data
Number of persons purchased
Plot placeholder
Mock data
Subscribe for the real data
Number of purchases
Plot placeholder
Mock data
Subscribe for the real data
Refill frequency
Plot placeholder
Mock data
Subscribe for the real data
Price per prescription (USD)
Plot placeholder
Mock data
Subscribe for the real data
Codeine
+
Guaifenesin
+
Phenylpropanolamine
Total medical expenditures per year (USD, in millions)
Plot placeholder
Mock data
Subscribe for the real data
Number of persons purchased
Plot placeholder
Mock data
Subscribe for the real data
Number of purchases
Plot placeholder
Mock data
Subscribe for the real data
Refill frequency
Plot placeholder
Mock data
Subscribe for the real data
Price per prescription (USD)
Plot placeholder
Mock data
Subscribe for the real data
Codeine
+
Phenylephrine
+
Promethazine
Total medical expenditures per year (USD, in millions)
Plot placeholder
Mock data
Subscribe for the real data
Number of persons purchased
Plot placeholder
Mock data
Subscribe for the real data
Number of purchases
Plot placeholder
Mock data
Subscribe for the real data
Refill frequency
Plot placeholder
Mock data
Subscribe for the real data
Price per prescription (USD)
Plot placeholder
Mock data
Subscribe for the real data
Codeine
+
Phenylephrine
+
Triprolidine
Total medical expenditures per year (USD, in millions)
Plot placeholder
Mock data
Subscribe for the real data
Number of persons purchased
Plot placeholder
Mock data
Subscribe for the real data
Number of purchases
Plot placeholder
Mock data
Subscribe for the real data
Refill frequency
Plot placeholder
Mock data
Subscribe for the real data
Price per prescription (USD)
Plot placeholder
Mock data
Subscribe for the real data
Codeine
+
Promethazine
Total medical expenditures per year (USD, in millions)
Plot placeholder
Mock data
Subscribe for the real data
Number of persons purchased
Plot placeholder
Mock data
Subscribe for the real data
Number of purchases
Plot placeholder
Mock data
Subscribe for the real data
Refill frequency
Plot placeholder
Mock data
Subscribe for the real data
Price per prescription (USD)
Plot placeholder
Mock data
Subscribe for the real data
Codeine
+
Pseudoephedrine
Total medical expenditures per year (USD, in millions)
Plot placeholder
Mock data
Subscribe for the real data
Number of persons purchased
Plot placeholder
Mock data
Subscribe for the real data
Number of purchases
Plot placeholder
Mock data
Subscribe for the real data
Refill frequency
Plot placeholder
Mock data
Subscribe for the real data
Price per prescription (USD)
Plot placeholder
Mock data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Plot placeholder
Mock data
Subscribe for the real data
Additional graphs summarizing 21,835 documents
View more details
Safety
Black-box Warning
Black-box warning for: Acetaminophen and codeine, Acetaminophen and codeine phosphate, Acetaminophen with codeine, Ascomp with codeine, Butalbital, acetaminophen, caffeine and codeine phosphate, Butalbital, acetaminophen, caffeine, and codeine phosphate, Butalbital, aspirin, caffeine and codeine phosphate, Codeine and chlorpheniramine maleate er, Codeine sulfate, Fioricet with codeine, Phenergan, Promethazine hci, Promethazine hcl, phenylephrine hcl, codeine phosphate, Promethazine hydrochloride and codeine phosphate, Promethazine hydrochloride and dextomethorphan hydrobromide, Promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate, Promethazine hydrochloride, phenylephrine hydrochloride, and codeine phosphate, Promethazine with codeine, Promethazine with codeine cough, Promethazine/codeine, Promethegan, Triacin-c, Tuxarin, Tylenol with codeine
Adverse Events
Top Adverse Reactions
Plot placeholder
Mock data
Subscribe for the real data
64,090 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use