FDA Orange Book
Generic for Prandin
Prandin contains repaglinide. 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 Prandin is repaglinide. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Prandin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.5MG | Discontinued | None | 3 | AB |
| tablet, oral | 1MG | Discontinued | None | 3 | AB |
| tablet, oral | 2MG | Discontinued | None | 3 | AB |
NDA 020741, held by GEMINI LABORATORIES LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic repaglinide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CHARTWELL RX SCIENCES LLC | 078555 | AB (A-rated, therapeutically equivalent) | November 22, 2013 | 0.5MG, 1MG, 2MG |
| AUROBINDO PHARMA LTD | 203820 | AB (A-rated, therapeutically equivalent) | January 22, 2014 | 0.5MG, 1MG, 2MG |
| MACLEODS PHARMACEUTICALS LTD | 207209 | AB (A-rated, therapeutically equivalent) | March 22, 2023 | 0.5MG, 1MG, 2MG |
Questions
Is there a generic for Prandin?
Yes. The generic name for Prandin is repaglinide. 3 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 Prandin?
The active ingredient in Prandin is repaglinide, 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.