FDA Orange Book
Generic for Carafate
Carafate contains sucralfate. 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 Carafate is sucralfate. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Carafate products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 1GM/10ML | Discontinued | None | 8 | AB |
| tablet, oral | 1GM | Marketed (Rx) | AB | 4 | AB |
NDA 019183, 018333, 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 sucralfate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 070848 | AB (A-rated, therapeutically equivalent) | March 29, 1996 | 1GM |
| CHARTWELL RX SCIENCES LLC | 074415 | AB (A-rated, therapeutically equivalent) | June 8, 1998 | 1GM |
| AMNEAL PHARMACEUTICALS LLC | 209356 | AB (A-rated, therapeutically equivalent) | December 2, 2019 | 1GM/10ML |
| VISTAPHARM LLC | 211884 | AB (A-rated, therapeutically equivalent) | March 15, 2022 | 1GM/10ML |
| AMNEAL PHARMACEUTICALS OF NEW YORK LLC | 215576 | AB (A-rated, therapeutically equivalent) | April 15, 2022 | 1GM |
| ZYDUS LIFESCIENCES LTD | 215705 | AB (A-rated, therapeutically equivalent) | May 3, 2023 | 1GM |
| PD PARTNERS III LLC | 213549 | AB (A-rated, therapeutically equivalent) | January 17, 2024 | 1GM/10ML |
| ABON PHARMACEUTICALS LLC | 216726 | AB (A-rated, therapeutically equivalent) | March 21, 2024 | 1GM/10ML |
| STRIDES PHARMA GLOBAL PTE LTD | 216474 | AB (A-rated, therapeutically equivalent) | May 21, 2024 | 1GM/10ML |
| COSETTE PHARMACEUTICALS NC LABORATORIES LLC | 217126 | AB (A-rated, therapeutically equivalent) | November 13, 2024 | 1GM/10ML |
| CHARTWELL RX SCIENCES LLC | 211780 | AB (A-rated, therapeutically equivalent) | April 14, 2025 | 1GM/10ML |
| GLENMARK PHARMACEUTICALS LTD | 212141 | AB (A-rated, therapeutically equivalent) | January 5, 2026 | 1GM/10ML |
Carafate NDC codes
Questions
Is there a generic for Carafate?
Yes. The generic name for Carafate is sucralfate. 11 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 Carafate?
The active ingredient in Carafate is sucralfate, 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.