FDA Orange Book
Is there a generic for Noritate?
Noritate 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Noritate (metronidazole).
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Noritate products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 1% | Marketed (Rx) | None | 0 | None |
NDA 020743, held by BAUSCH HEALTH US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Noritate NDC codes
Questions
Is there a generic for Noritate?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Noritate (metronidazole).
What is the generic name for Noritate?
The active ingredient in Noritate 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.
More on Noritate and Metronidazole
- What is Metronidazole used for?FDA label uses
- Is Metronidazole a controlled substance?Federal schedule
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- Nitroimidazole Antimicrobials listFDA drug class
- NDC 0187-5202Noritate NDC record