FDA Orange Book
Generic for Demulen 1/50-28
Demulen 1/50-28 contains ethinyl estradiol and ethynodiol diacetate. 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 Demulen 1/50-28 is ethinyl estradiol and ethynodiol diacetate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Demulen 1/50-28 products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral-28 | 0.05MG;1MG | Discontinued | None | 2 | AB |
NDA 016936, held by GD SEARLE LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ethinyl estradiol and ethynodiol diacetate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| XIROMED LLC | 204704 | AB (A-rated, therapeutically equivalent) | February 9, 2016 | 0.05MG;1MG |
| NOVAST LABORATORIES LTD | 209547 | AB (A-rated, therapeutically equivalent) | July 25, 2018 | 0.05MG;1MG |
Questions
Is there a generic for Demulen 1/50-28?
Yes. The generic name for Demulen 1/50-28 is ethinyl estradiol and ethynodiol diacetate. 2 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 Demulen 1/50-28?
The active ingredient in Demulen 1/50-28 is ethinyl estradiol and ethynodiol diacetate, 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.