FDA Orange Book
Generic for Metrocream
Metrocream contains metronidazole. 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 Metrocream is metronidazole. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX.
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Metrocream products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 0.75% | Marketed (Rx) | AB | 4 | AB, BX |
NDA 020531, held by GALDERMA LABORATORIES LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic metronidazole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FOUGERA PHARMACEUTICALS INC | 076408 | AB (A-rated, therapeutically equivalent) | May 28, 2004 | 0.75% |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 077549 | AB (A-rated, therapeutically equivalent) | December 19, 2007 | 0.75% |
| ZYDUS LIFESCIENCES LTD | 217128 | BX (B-rated, not considered equivalent) | April 21, 2023 | 0.75% |
| AUROBINDO PHARMA LTD | 219295 | AB (A-rated, therapeutically equivalent) | July 9, 2025 | 0.75% |
Metrocream NDC codes
Questions
Is there a generic for Metrocream?
Yes. The generic name for Metrocream is metronidazole. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX.
What is the generic name for Metrocream?
The active ingredient in Metrocream is metronidazole, 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.