FDA Orange Book
Generic for Niaspan
Niaspan contains niacin. 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 Niaspan is niacin. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Niaspan products the Orange Book lists.
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Niaspan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 1GM | Discontinued | None | 9 | AB |
| tablet, extended release, oral | 375MG | Discontinued | None | 0 | None |
| tablet, extended release, oral | 500MG | Discontinued | None | 9 | AB |
| tablet, extended release, oral | 750MG | Discontinued | None | 7 | AB |
NDA 020381, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic niacin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BARR LABORATORIES INC | 076250 | AB (A-rated, therapeutically equivalent) | April 14, 2005 | 1GM |
| BARR LABORATORIES INC | 076378 | AB (A-rated, therapeutically equivalent) | April 26, 2005 | 500MG, 750MG |
| CHARTWELL RX SCIENCES LLC | 090446 | AB (A-rated, therapeutically equivalent) | March 20, 2014 | 1GM |
| CHARTWELL RX SCIENCES LLC | 090860 | AB (A-rated, therapeutically equivalent) | March 20, 2014 | 500MG |
| CHARTWELL RX SCIENCES LLC | 090892 | AB (A-rated, therapeutically equivalent) | March 20, 2014 | 750MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 200484 | AB (A-rated, therapeutically equivalent) | April 23, 2014 | 1GM, 500MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 201273 | AB (A-rated, therapeutically equivalent) | April 23, 2014 | 750MG |
| AMNEAL PHARMACEUTICALS | 203578 | AB (A-rated, therapeutically equivalent) | July 24, 2015 | 1GM, 500MG |
| AMNEAL PHARMACEUTICALS | 204178 | AB (A-rated, therapeutically equivalent) | December 11, 2015 | 750MG |
| QUAGEN PHARMACEUTICALS LLC | 203899 | AB (A-rated, therapeutically equivalent) | June 16, 2017 | 1GM, 500MG |
| AUROBINDO PHARMA LTD | 209236 | AB (A-rated, therapeutically equivalent) | February 1, 2018 | 1GM, 500MG, 750MG |
| MACLEODS PHARMACEUTICALS LTD | 204934 | AB (A-rated, therapeutically equivalent) | March 3, 2022 | 1GM, 500MG |
| ADAPTIS PHARMA PRIVATE LTD | 213090 | AB (A-rated, therapeutically equivalent) | August 25, 2023 | 1GM, 500MG, 750MG |
| MPP PHARMA LLC | 207726 | AB (A-rated, therapeutically equivalent) | July 25, 2025 | 1GM, 500MG, 750MG |
Questions
Is there a generic for Niaspan?
Yes. The generic name for Niaspan is niacin. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Niaspan products the Orange Book lists.
What is the generic name for Niaspan?
The active ingredient in Niaspan is niacin, 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.