FDA Orange Book
Generic for Zegerid
Zegerid contains omeprazole and sodium bicarbonate. 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 Zegerid is omeprazole and sodium bicarbonate. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 6 Zegerid products the Orange Book lists.
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Zegerid products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 20MG;1.1GM | Discontinued | None | 6 | AB |
| capsule, oral | 40MG;1.1GM | Discontinued | None | 6 | AB |
| for suspension, oral | 20MG/PACKET;1.68GM/PACKET | Discontinued | None | 3 | AB |
| for suspension, oral | 40MG/PACKET;1.68GM/PACKET | Discontinued | None | 3 | AB |
| tablet, chewable, oral | 700MG;20MG;600MG | Discontinued | None | 0 | None |
| tablet, chewable, oral | 700MG;40MG;600MG | Discontinued | None | 0 | None |
NDA 021849, 021636, 021850, held by SALIX PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic omeprazole and sodium bicarbonate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| STRIDES PHARMA INTERNATIONAL AG | 079182 | AB (A-rated, therapeutically equivalent) | April 19, 2013 | 20MG/PACKET;1.68GM/PACKET, 40MG/PACKET;1.68GM/PACKET |
| AJANTA PHARMA LTD | 204228 | AB (A-rated, therapeutically equivalent) | July 15, 2016 | 20MG;1.1GM, 40MG;1.1GM |
| DR REDDYS LABORATORIES LTD | 204068 | AB (A-rated, therapeutically equivalent) | July 15, 2016 | 20MG;1.1GM, 40MG;1.1GM |
| AJANTA PHARMA LTD | 205545 | AB (A-rated, therapeutically equivalent) | July 27, 2016 | 20MG/PACKET;1.68GM/PACKET, 40MG/PACKET;1.68GM/PACKET |
| AUROLIFE PHARMA LLC | 204922 | AB (A-rated, therapeutically equivalent) | August 19, 2016 | 20MG;1.1GM, 40MG;1.1GM |
| SCIEGEN PHARMACEUTICALS INC | 207476 | AB (A-rated, therapeutically equivalent) | December 6, 2016 | 20MG;1.1GM, 40MG;1.1GM |
| ZYDUS PHARMACEUTICALS USA INC | 203290 | AB (A-rated, therapeutically equivalent) | May 25, 2018 | 20MG;1.1GM, 40MG;1.1GM |
| ADAPTIS PHARMA PRIVATE LTD | 212587 | AB (A-rated, therapeutically equivalent) | April 30, 2020 | 20MG;1.1GM, 40MG;1.1GM |
| NOVITIUM PHARMA LLC | 219161 | AB (A-rated, therapeutically equivalent) | December 10, 2025 | 20MG/PACKET;1.68GM/PACKET, 40MG/PACKET;1.68GM/PACKET |
Zegerid NDC codes
Questions
Is there a generic for Zegerid?
Yes. The generic name for Zegerid is omeprazole and sodium bicarbonate. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 6 Zegerid products the Orange Book lists.
What is the generic name for Zegerid?
The active ingredient in Zegerid is omeprazole and sodium bicarbonate, 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.