FDA Orange Book
Generic for Norinyl 1+35 28-day
Norinyl 1+35 28-day contains norethindrone and ethinyl estradiol. 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 Norinyl 1+35 28-day is norethindrone and ethinyl estradiol. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Norinyl 1+35 28-day products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral-28 | 0.035MG;1MG | Discontinued | None | 6 | AB |
NDA 017565, held by ALLERGAN SALES LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic norethindrone and ethinyl estradiol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 070687 | AB (A-rated, therapeutically equivalent) | January 29, 1987 | 0.035MG;1MG |
| BARR LABORATORIES LLC (AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC) | 072696 | AB (A-rated, therapeutically equivalent) | February 28, 1992 | 0.035MG;1MG |
| NOVAST LABORATORIES LTD | 090948 | AB (A-rated, therapeutically equivalent) | December 22, 2011 | 0.035MG;1MG |
| GLENMARK PHARMACEUTICALS LTD | 091634 | AB (A-rated, therapeutically equivalent) | January 19, 2012 | 0.035MG;1MG |
| AUROBINDO PHARMA LTD | 207056 | AB (A-rated, therapeutically equivalent) | October 21, 2016 | 0.035MG;1MG |
| NAARI PTE LTD | 206864 | AB (A-rated, therapeutically equivalent) | April 28, 2017 | 0.035MG;1MG |
Questions
Is there a generic for Norinyl 1+35 28-day?
Yes. The generic name for Norinyl 1+35 28-day is norethindrone and ethinyl estradiol. 6 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 Norinyl 1+35 28-day?
The active ingredient in Norinyl 1+35 28-day is norethindrone and ethinyl estradiol, 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.