FDA Orange Book
Generic for Norlutate
Norlutate contains norethindrone acetate. 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 Norlutate is norethindrone acetate. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Norlutate products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 5MG | Discontinued | None | 5 | AB |
NDA 012184, held by PARKE DAVIS DIV WARNER LAMBERT CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic norethindrone acetate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BARR LABORATORIES INC | 075951 | AB (A-rated, therapeutically equivalent) | May 25, 2001 | 5MG |
| GLENMARK PHARMACEUTICALS LTD | 091090 | AB (A-rated, therapeutically equivalent) | July 21, 2010 | 5MG |
| AMNEAL PHARMACEUTICALS | 200275 | AB (A-rated, therapeutically equivalent) | July 30, 2012 | 5MG |
| XIROMED LLC | 205278 | AB (A-rated, therapeutically equivalent) | November 10, 2016 | 5MG |
| INGENUS PHARMACEUTICALS LLC | 206490 | AB (A-rated, therapeutically equivalent) | November 5, 2018 | 5MG |
Questions
Is there a generic for Norlutate?
Yes. The generic name for Norlutate is norethindrone acetate. 5 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 Norlutate?
The active ingredient in Norlutate is norethindrone acetate, 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.