FDA Orange Book · active-ingredient family
Cefdinir
Cefdinir: 2 brands, 12 generics; first approved Dec 04, 1997; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 12 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
12
Listed patents
0
Presentations
21
Brand (NDA) products
Originator applications
- OMNICEFRLDABBVIENDA 0507391997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG CAPSULE ORAL Discontinued — - OMNICEFRLDABBVIENDA 05074919972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/5ML FOR SUSPENSION ORAL Discontinued — 250MG/5ML FOR SUSPENSION ORAL Discontinued —
Generic (ANDA) products (12)
Abbreviated applications
- CEFDINIRALKEM LABS LTDANDA 2102202021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG CAPSULE ORAL Rx AB - CEFDINIRALKEM LABS LTDANDA 21053420212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/5ML FOR SUSPENSION ORAL Rx AB 250MG/5ML FOR SUSPENSION ORAL Rx AB - CEFDINIRAUROBINDO PHARMAANDA 0654342008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG CAPSULE ORAL Rx AB - CEFDINIRAUROBINDO PHARMAANDA 06547320072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/5ML FOR SUSPENSION ORAL Rx AB 250MG/5ML FOR SUSPENSION ORAL Rx AB - CEFDINIRANDA REPOSITORYANDA 0654182007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG CAPSULE ORAL Rx AB - CEFDINIRANDA REPOSITORYANDA 06542920072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/5ML FOR SUSPENSION ORAL Rx AB 250MG/5ML FOR SUSPENSION ORAL Rx AB - CEFDINIRTEVA PHARMSANDA 0653682007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG CAPSULE ORAL Rx AB - CEFDINIRTEVA PHARMSANDA 06533220072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/5ML FOR SUSPENSION ORAL Rx AB 250MG/5ML FOR SUSPENSION ORAL Rx AB - CEFDINIRRSCHARTWELL RXANDA 0653302007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG CAPSULE ORAL Rx AB - CEFDINIRCHARTWELL RXANDA 06533720072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/5ML FOR SUSPENSION ORAL Rx AB 250MG/5ML FOR SUSPENSION ORAL Rx AB - CEFDINIRLUPINANDA 06525920062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG/5ML FOR SUSPENSION ORAL Rx AB 250MG/5ML FOR SUSPENSION ORAL Rx AB - CEFDINIRLUPINANDA 0652642006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG CAPSULE 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
29 yr 2 mo ago
Most recent approval
5 yr 7 mo ago
Approvals span 1997–2021 across 14 FDA applications.
Brand (NDA) 214%
Generic (ANDA) 1286%
Cefdinir: 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.
