FDA Orange Book
Generic for Welchol
Welchol contains colesevelam. 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 Welchol is colesevelam. 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 5 Welchol products the Orange Book lists.
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Welchol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| bar, chewable, oral | 3.75GM | Discontinued | None | 0 | None |
| capsule, oral | 375MG | Discontinued | None | 0 | None |
| for suspension, oral | 1.875GM/PACKET | Discontinued | None | 1 | None |
| for suspension, oral | 3.75GM/PACKET | Marketed (Rx) | AB | 2 | AB |
| tablet, oral | 625MG | Marketed (Rx) | AB | 9 | AB |
NDA 210895, 021141, 022362, 021176, held by COSETTE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic colesevelam
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| IMPAX LABORATORIES INC | 091600 | AB (A-rated, therapeutically equivalent) | May 16, 2018 | 625MG |
| GLENMARK PHARMACEUTICALS LTD | 203480 | AB (A-rated, therapeutically equivalent) | May 18, 2018 | 625MG |
| GLENMARK PHARMACEUTICALS LTD | 202190 | None (No TE code listed) | July 16, 2018 | 1.875GM/PACKET, 3.75GM/PACKET |
| ALKEM LABORATORIES LTD | 209038 | AB (A-rated, therapeutically equivalent) | October 5, 2018 | 625MG |
| DR REDDYS LABORATORIES LTD | 210889 | AB (A-rated, therapeutically equivalent) | October 5, 2018 | 625MG |
| ALKEM LABORATORIES LTD | 210316 | AB (A-rated, therapeutically equivalent) | May 6, 2019 | 3.75GM/PACKET |
| BIONPHARMA INC | 208670 | AB (A-rated, therapeutically equivalent) | September 13, 2019 | 625MG |
| ZYDUS PHARMACEUTICALS USA INC | 207765 | AB (A-rated, therapeutically equivalent) | October 7, 2019 | 625MG |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO LTD | 209946 | AB (A-rated, therapeutically equivalent) | July 15, 2020 | 625MG |
| ADAPTIS PHARMA PRIVATE LTD | 212050 | AB (A-rated, therapeutically equivalent) | December 4, 2020 | 625MG |
| BEIJING TIDE PHARMACEUTICAL CO LTD | 206036 | AB (A-rated, therapeutically equivalent) | October 14, 2021 | 625MG |
Welchol NDC codes
Questions
Is there a generic for Welchol?
Yes. The generic name for Welchol is colesevelam. 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 5 Welchol products the Orange Book lists.
What is the generic name for Welchol?
The active ingredient in Welchol is colesevelam, 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.