FDA Orange Book
Generic for Ovcon-35
Ovcon-35 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 Ovcon-35 is norethindrone and ethinyl estradiol. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Ovcon-35 products the Orange Book lists.
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Ovcon-35 products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral-21 | 0.035MG;0.4MG | Discontinued | None | 0 | None |
| tablet, oral-28 | 0.035MG;0.4MG | Discontinued | None | 5 | AB |
NDA 018127, 017716, held by WARNER CHILCOTT INC. 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 |
|---|---|---|---|---|
| BARR LABORATORIES INC | 076238 | AB (A-rated, therapeutically equivalent) | April 22, 2004 | 0.035MG;0.4MG |
| WATSON LABORATORIES INC | 078323 | AB (A-rated, therapeutically equivalent) | February 4, 2010 | 0.035MG;0.4MG |
| GLENMARK PHARMACEUTICALS LTD | 090538 | AB (A-rated, therapeutically equivalent) | March 22, 2011 | 0.035MG;0.4MG |
| NOVAST LABORATORIES LTD | 090947 | AB (A-rated, therapeutically equivalent) | December 22, 2011 | 0.035MG;0.4MG |
| LUPIN LTD | 201886 | AB (A-rated, therapeutically equivalent) | September 26, 2013 | 0.035MG;0.4MG |
Questions
Is there a generic for Ovcon-35?
Yes. The generic name for Ovcon-35 is norethindrone and ethinyl estradiol. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Ovcon-35 products the Orange Book lists.
What is the generic name for Ovcon-35?
The active ingredient in Ovcon-35 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.