FDA Orange Book
Generic for Cefotan
Cefotan contains cefotetan. 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 Cefotan is cefotetan. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 3 Cefotan products the Orange Book lists.
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Cefotan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 10GM BASE/VIAL | Discontinued | None | 0 | None |
| injectable, injection | EQ 1GM BASE/VIAL | Marketed (Rx) | AP | 1 | AP |
| injectable, injection | EQ 2GM BASE/VIAL | Marketed (Rx) | AP | 1 | AP |
NDA 050588, held by PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic cefotetan
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FRESENIUS KABI USA LLC | 065374 | AP (A-rated, therapeutically equivalent) | August 9, 2007 | EQ 1GM BASE/VIAL, EQ 2GM BASE/VIAL |
Cefotan NDC codes
Questions
Is there a generic for Cefotan?
Yes. The generic name for Cefotan is cefotetan. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 3 Cefotan products the Orange Book lists.
What is the generic name for Cefotan?
The active ingredient in Cefotan is cefotetan, 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.