FDA Orange Book
Generic for Ortho-novum 7/14-28
Ortho-novum 7/14-28 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 Ortho-novum 7/14-28 is norethindrone and ethinyl estradiol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
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Ortho-novum 7/14-28 products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral-28 | 0.035MG,0.035MG;0.5MG,1MG | Discontinued | None | 1 | None |
NDA 019004, 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 |
|---|---|---|---|---|
| WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 071044 | None (No TE code listed) | April 1, 1988 | 0.035MG,0.035MG;0.5MG,1MG |
Questions
Is there a generic for Ortho-novum 7/14-28?
Yes. The generic name for Ortho-novum 7/14-28 is norethindrone and ethinyl estradiol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
What is the generic name for Ortho-novum 7/14-28?
The active ingredient in Ortho-novum 7/14-28 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.