FDA Orange Book
Generic for Tri-norinyl 28-day
Tri-norinyl 28-day 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 Tri-norinyl 28-day 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.
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Tri-norinyl 28-day 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,0.035MG;0.5MG,1MG,0.5MG | Marketed (Rx) | AB | 1 | AB |
NDA 018977, held by DR REDDYS LABORATORIES SA. 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 | 076783 | AB (A-rated, therapeutically equivalent) | September 29, 2004 | 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG |
Questions
Is there a generic for Tri-norinyl 28-day?
Yes. The generic name for Tri-norinyl 28-day 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 Tri-norinyl 28-day?
The active ingredient in Tri-norinyl 28-day 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.