FDA Orange Book
Generic for Prilosec
Prilosec contains omeprazole. 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 Prilosec is omeprazole. 13 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 Prilosec products the Orange Book lists.
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Prilosec products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, delayed rel pellets, oral | 10MG | Discontinued | None | 13 | AB |
| capsule, delayed rel pellets, oral | 20MG | Discontinued | None | 14 | AB |
| capsule, delayed rel pellets, oral | 40MG | Discontinued | None | 12 | AB |
| for suspension, delayed release, oral | EQ 10MG BASE/PACKET | Marketed (Rx) | None | 0 | None |
| for suspension, delayed release, oral | EQ 2.5MG BASE/PACKET | Marketed (Rx) | None | 0 | None |
NDA 019810, 022056, held by ASTRAZENECA PHARMACEUTICALS LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic omeprazole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| LANNETT CO INC | 075410 | AB (A-rated, therapeutically equivalent) | November 1, 2002 | 10MG, 20MG, 40MG |
| SANDOZ INC | 075757 | AB (A-rated, therapeutically equivalent) | January 28, 2003 | 10MG, 20MG |
| APOTEX INC | 076048 | AB (A-rated, therapeutically equivalent) | October 22, 2007 | 10MG, 20MG, 40MG |
| DR REDDYS LABORATORIES LTD | 075576 | AB (A-rated, therapeutically equivalent) | October 22, 2007 | 10MG, 20MG, 40MG |
| IMPAX LABORATORIES INC | 075785 | AB (A-rated, therapeutically equivalent) | October 22, 2007 | 10MG, 20MG, 40MG |
| ACTAVIS LABORATORIES FL INC | 075347 | AB (A-rated, therapeutically equivalent) | May 30, 2008 | 10MG, 20MG, 40MG |
| SANDOZ INC | 076515 | AB (A-rated, therapeutically equivalent) | January 21, 2009 | 40MG |
| DR REDDYS LABORATORIES LTD | 078490 | AB (A-rated, therapeutically equivalent) | March 16, 2009 | 10MG, 20MG, 40MG |
| ZYDUS PHARMACEUTICALS USA INC | 091352 | AB (A-rated, therapeutically equivalent) | November 19, 2012 | 10MG, 20MG, 40MG |
| GLENMARK PHARMACEUTICALS LTD | 091672 | AB (A-rated, therapeutically equivalent) | October 31, 2014 | 10MG, 20MG, 40MG |
| AUROBINDO PHARMA LTD | 203270 | AB (A-rated, therapeutically equivalent) | August 19, 2015 | 10MG, 20MG, 40MG |
| TEVA PHARMACEUTICALS USA | 204661 | AB (A-rated, therapeutically equivalent) | June 13, 2017 | 20MG |
| BRECKENRIDGE PHARMACEUTICAL INC | 203481 | AB (A-rated, therapeutically equivalent) | July 3, 2017 | 10MG, 20MG, 40MG |
| HETERO LABS LTD UNIT III | 204012 | AB (A-rated, therapeutically equivalent) | September 26, 2019 | 10MG, 20MG |
| XIROMED PHARMA ESPANA SL | 212977 | AB (A-rated, therapeutically equivalent) | December 10, 2020 | 10MG, 20MG, 40MG |
Prilosec NDC codes
Questions
Is there a generic for Prilosec?
Yes. The generic name for Prilosec is omeprazole. 13 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 Prilosec products the Orange Book lists.
What is the generic name for Prilosec?
The active ingredient in Prilosec is omeprazole, 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.