FDA Orange Book
Generic for Omnicef
Omnicef contains cefdinir. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Omnicef is cefdinir. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Omnicef products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 300MG | Discontinued | None | 6 | AB |
| for suspension, oral | 125MG/5ML | Discontinued | None | 6 | AB |
| for suspension, oral | 250MG/5ML | Discontinued | None | 6 | AB |
NDA 050739, 050749, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic cefdinir
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| LUPIN LTD | 065264 | AB (A-rated, therapeutically equivalent) | May 19, 2006 | 300MG |
| LUPIN LTD | 065259 | AB (A-rated, therapeutically equivalent) | May 31, 2006 | 125MG/5ML, 250MG/5ML |
| CHARTWELL RX SCIENCES LLC | 065330 | AB (A-rated, therapeutically equivalent) | April 6, 2007 | 300MG |
| CHARTWELL RX SCIENCES LLC | 065337 | AB (A-rated, therapeutically equivalent) | April 6, 2007 | 125MG/5ML, 250MG/5ML |
| TEVA PHARMACEUTICALS USA | 065332 | AB (A-rated, therapeutically equivalent) | May 4, 2007 | 125MG/5ML, 250MG/5ML |
| TEVA PHARMACEUTICALS USA | 065368 | AB (A-rated, therapeutically equivalent) | May 9, 2007 | 300MG |
| ANDA REPOSITORY LLC | 065418 | AB (A-rated, therapeutically equivalent) | July 18, 2007 | 300MG |
| ANDA REPOSITORY LLC | 065429 | AB (A-rated, therapeutically equivalent) | July 18, 2007 | 125MG/5ML, 250MG/5ML |
| AUROBINDO PHARMA LTD | 065473 | AB (A-rated, therapeutically equivalent) | December 14, 2007 | 125MG/5ML, 250MG/5ML |
| AUROBINDO PHARMA LTD | 065434 | AB (A-rated, therapeutically equivalent) | January 7, 2008 | 300MG |
| ALKEM LABORATORIES LTD | 210220 | AB (A-rated, therapeutically equivalent) | February 19, 2021 | 300MG |
| ALKEM LABORATORIES LTD | 210534 | AB (A-rated, therapeutically equivalent) | February 19, 2021 | 125MG/5ML, 250MG/5ML |
Questions
Is there a generic for Omnicef?
Yes. The generic name for Omnicef is cefdinir. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Omnicef?
The active ingredient in Omnicef is cefdinir, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.