FDA Orange Book
Generic for Catapres
Catapres contains clonidine. 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 Catapres is clonidine. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Catapres 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.
Catapres products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.1MG | Discontinued | None | 9 | AB |
| tablet, oral | 0.2MG | Discontinued | None | 9 | AB |
| tablet, oral | 0.3MG | Discontinued | None | 9 | AB |
NDA 017407, held by BOEHRINGER INGELHEIM. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic clonidine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS ELIZABETH LLC | 070974 | AB (A-rated, therapeutically equivalent) | December 16, 1986 | 0.1MG |
| ACTAVIS ELIZABETH LLC | 070975 | AB (A-rated, therapeutically equivalent) | December 16, 1986 | 0.2MG |
| ACTAVIS ELIZABETH LLC | 070976 | AB (A-rated, therapeutically equivalent) | December 16, 1986 | 0.3MG |
| TP ANDA HOLDINGS LLC | 070923 | AB (A-rated, therapeutically equivalent) | September 4, 1987 | 0.1MG, 0.2MG, 0.3MG |
| CHARTWELL MOLECULES LLC | 071785 | AB (A-rated, therapeutically equivalent) | April 5, 1988 | 0.1MG, 0.2MG, 0.3MG |
| AUROBINDO PHARMA LTD | 070886 | AB (A-rated, therapeutically equivalent) | August 31, 1988 | 0.1MG, 0.2MG, 0.3MG |
| PRINSTON PHARMACEUTICAL INC | 077901 | AB (A-rated, therapeutically equivalent) | March 9, 2007 | 0.1MG, 0.2MG, 0.3MG |
| UNICHEM LABORATORIES LTD | 078895 | AB (A-rated, therapeutically equivalent) | August 26, 2009 | 0.1MG, 0.2MG, 0.3MG |
| IMPAX LABORATORIES INC | 078099 | AB (A-rated, therapeutically equivalent) | August 27, 2009 | 0.1MG, 0.2MG, 0.3MG |
| ALEMBIC PHARMACEUTICALS LTD | 091368 | AB (A-rated, therapeutically equivalent) | December 6, 2011 | 0.1MG, 0.2MG, 0.3MG |
| YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD | 202297 | AB (A-rated, therapeutically equivalent) | June 13, 2013 | 0.1MG, 0.2MG, 0.3MG |
Questions
Is there a generic for Catapres?
Yes. The generic name for Catapres is clonidine. 9 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 Catapres?
The active ingredient in Catapres is clonidine, 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.