FDA Orange Book
Generic for Activella
Activella contains estradiol and norethindrone acetate. 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 Activella is estradiol and norethindrone acetate. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX.
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Activella products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.5MG;0.1MG | Discontinued | None | 4 | AB, BX |
| tablet, oral | 1MG;0.5MG | Marketed (Rx) | AB | 6 | AB, BX |
NDA 020907, held by AMNEAL PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic estradiol and norethindrone acetate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BARR LABORATORIES INC | 079193 | AB (A-rated, therapeutically equivalent) | May 11, 2010 | 1MG;0.5MG |
| BRECKENRIDGE PHARMACEUTICAL INC | 078324 | AB (A-rated, therapeutically equivalent) | June 9, 2011 | 0.5MG;0.1MG, 1MG;0.5MG |
| LUPIN LTD | 203339 | BX (B-rated, not considered equivalent) | June 20, 2016 | 0.5MG;0.1MG, 1MG;0.5MG |
| XIROMED LLC | 207261 | AB (A-rated, therapeutically equivalent) | February 10, 2017 | 0.5MG;0.1MG, 1MG;0.5MG |
| NAARI PTE LTD | 210233 | AB (A-rated, therapeutically equivalent) | February 28, 2018 | 1MG;0.5MG |
| NOVAST LABORATORIES LTD | 210612 | AB (A-rated, therapeutically equivalent) | April 3, 2019 | 0.5MG;0.1MG, 1MG;0.5MG |
Activella NDC codes
Questions
Is there a generic for Activella?
Yes. The generic name for Activella is estradiol and norethindrone acetate. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX.
What is the generic name for Activella?
The active ingredient in Activella is estradiol and norethindrone acetate, 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.