FDA Orange Book
Generic for Precose
Precose contains acarbose. 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 Precose is acarbose. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Precose products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Discontinued | None | 5 | AB |
| tablet, oral | 25MG | Discontinued | None | 5 | AB |
| tablet, oral | 50MG | Discontinued | None | 5 | AB |
NDA 020482, held by BAYER HEALTHCARE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic acarbose
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 078470 | AB (A-rated, therapeutically equivalent) | May 7, 2008 | 100MG, 25MG, 50MG |
| WATSON LABORATORIES INC | 077532 | AB (A-rated, therapeutically equivalent) | May 7, 2008 | 100MG, 25MG, 50MG |
| IMPAX LABORATORIES INC | 078441 | AB (A-rated, therapeutically equivalent) | May 14, 2009 | 100MG, 25MG, 50MG |
| STRIDES PHARMA GLOBAL PTE LTD | 090912 | AB (A-rated, therapeutically equivalent) | July 27, 2011 | 100MG, 25MG, 50MG |
| SOMERSET THERAPEUTICS LLC | 091343 | AB (A-rated, therapeutically equivalent) | October 17, 2013 | 100MG, 25MG, 50MG |
Questions
Is there a generic for Precose?
Yes. The generic name for Precose is acarbose. 5 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 Precose?
The active ingredient in Precose is acarbose, 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.