NDC directory
Generic for Ortho-novum 1/35-21
Ortho-novum 1/35-21 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
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Yes. The generic name for Ortho-novum 1/35-21 is norethindrone and ethinyl estradiol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Ortho-novum 1/35-21 products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral-21 | 0.035MG;1MG | Discontinued | None | 1 | AB |
NDA 017489, 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.
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Approved generic norethindrone and ethinyl estradiol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BARR LABORATORIES INC | 072693 | AB (A-rated, therapeutically equivalent) | February 28, 1992 | 0.035MG;1MG |
Questions
Is there a generic for Ortho-novum 1/35-21?
Yes. The generic name for Ortho-novum 1/35-21 is norethindrone and ethinyl estradiol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Ortho-novum 1/35-21?
The active ingredient in Ortho-novum 1/35-21 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.
More on Ortho-novum 1/35-21 and Norethindrone and Ethinyl Estradiol
Pharmacies near you
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Map Ortho-novum 1/35-21 and your other top fills to their generics
Rivvi lists each brand, its generics in RxNorm, and the brands with no generic.
Map my fillsFree to start. Opens Rivvi, the AI workspace for healthcare teams.
2M+ interactions500K+ patientsHIPAA BAA