FDA Orange Book · active-ingredient family
Codeine sulfate
Codeine sulfate: 2 brands, 1 generic; first approved Jul 16, 2009; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 1 ANDA application approved.
Brands (NDA)
2
Generics (ANDA)
1
Listed patents
0
Presentations
7
Brand (NDA) products
Originator applications
- CODEINE SULFATERLDHIKMANDA 02240220093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB - CODEINE SULFATEHIKMANDA 2022452011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/5ML SOLUTION ORAL Discontinued —
Generic (ANDA) products (1)
Abbreviated applications
- CODEINE SULFATELANNETT CO INCANDA 20304620143 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 15MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
17 yr 4 mo ago
Most recent approval
12 yr 4 mo ago
Approvals span 2009–2014 across 3 FDA applications.
Brand (NDA) 267%
Generic (ANDA) 133%
Codeine sulfate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
