FDA Orange Book
Generic for Aygestin
Aygestin 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 Aygestin is norethindrone acetate. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Aygestin and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Aygestin 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 018405, held by DURAMED RESEARCH INC. 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 Aygestin?
Yes. The generic name for Aygestin 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 Aygestin?
The active ingredient in Aygestin 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.