FDA Orange Book
Generic for Brethine
Brethine contains terbutaline. 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 Brethine is terbutaline. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
Run it in Rivvi
Map Brethine and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Brethine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 1MG/ML | Discontinued | None | 3 | AP |
| tablet, oral | 2.5MG | Marketed (Rx) | AB | 2 | AB |
| tablet, oral | 5MG | Marketed (Rx) | AB | 2 | AB |
NDA 018571, 017849, held by PHARMACARE LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic terbutaline
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| IMPAX LABORATORIES INC | 075877 | AB (A-rated, therapeutically equivalent) | June 26, 2001 | 2.5MG, 5MG |
| FRESENIUS KABI USA LLC | 076887 | AP (A-rated, therapeutically equivalent) | May 26, 2004 | 1MG/ML |
| LANNETT CO INC | 077152 | AB (A-rated, therapeutically equivalent) | March 25, 2005 | 2.5MG, 5MG |
| HIKMA FARMACEUTICA (PORTUGAL) SA | 078630 | AP (A-rated, therapeutically equivalent) | May 20, 2009 | 1MG/ML |
| AREVA PHARMACEUTICALS INC | 200122 | AP (A-rated, therapeutically equivalent) | November 8, 2013 | 1MG/ML |
Brethine NDC codes
Questions
Is there a generic for Brethine?
Yes. The generic name for Brethine is terbutaline. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
What is the generic name for Brethine?
The active ingredient in Brethine is terbutaline, 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.