FDA Orange Book
Generic for Modicon
Modicon 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 Modicon is norethindrone and ethinyl estradiol. 3 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 Modicon products the Orange Book lists.
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Modicon products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral-21 | 0.035MG;0.5MG | Discontinued | None | 0 | None |
| tablet, oral-28 | 0.035MG;0.5MG | Discontinued | None | 3 | AB |
NDA 017488, 017735, held by ORTHO MCNEIL PHARMACEUTICAL 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 LLC (AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC) | 072695 | AB (A-rated, therapeutically equivalent) | February 28, 1992 | 0.035MG;0.5MG |
| NOVAST LABORATORIES LTD | 091204 | AB (A-rated, therapeutically equivalent) | March 27, 2012 | 0.035MG;0.5MG |
| AUROBINDO PHARMA LTD | 207055 | AB (A-rated, therapeutically equivalent) | October 21, 2016 | 0.035MG;0.5MG |
Questions
Is there a generic for Modicon?
Yes. The generic name for Modicon is norethindrone and ethinyl estradiol. 3 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 Modicon products the Orange Book lists.
What is the generic name for Modicon?
The active ingredient in Modicon 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.