FDA Orange Book
Generic for Prevacid
Prevacid contains lansoprazole. 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 Prevacid is lansoprazole. 13 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 Prevacid products the Orange Book lists.
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Prevacid products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, delayed rel pellets, oral | 15MG | Discontinued | None | 11 | AB |
| capsule, delayed rel pellets, oral | 30MG | Marketed (Rx) | AB | 11 | AB |
| for suspension, delayed release, oral | 15MG/PACKET | Discontinued | None | 0 | None |
| for suspension, delayed release, oral | 30MG/PACKET | Discontinued | None | 0 | None |
| tablet, orally disintegrating, delayed release, oral | 15MG | Marketed (Rx) | AB | 5 | AB |
| tablet, orally disintegrating, delayed release, oral | 30MG | Marketed (Rx) | AB | 5 | AB |
NDA 020406, 021281, 021428, held by TAKEDA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic lansoprazole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 090763 | AB (A-rated, therapeutically equivalent) | November 10, 2009 | 15MG, 30MG |
| TEVA PHARMACEUTICALS USA | 077255 | AB (A-rated, therapeutically equivalent) | November 10, 2009 | 15MG, 30MG |
| DR REDDYS LABORATORIES LTD | 091269 | AB (A-rated, therapeutically equivalent) | October 15, 2010 | 15MG, 30MG |
| APOTEX INC | 202176 | AB (A-rated, therapeutically equivalent) | September 14, 2012 | 15MG, 30MG |
| NATCO PHARMA LTD | 201921 | AB (A-rated, therapeutically equivalent) | December 18, 2012 | 15MG, 30MG |
| ZYDUS HEALTHCARE USA LLC | 202366 | AB (A-rated, therapeutically equivalent) | August 19, 2013 | 15MG, 30MG |
| XIROMED PHARMA ESPANA SL | 203203 | AB (A-rated, therapeutically equivalent) | July 25, 2016 | 15MG, 30MG |
| ADAPTIS PHARMA PRIVATE LTD | 205868 | AB (A-rated, therapeutically equivalent) | August 30, 2017 | 15MG, 30MG |
| TEVA PHARMACEUTICALS USA | 208784 | AB (A-rated, therapeutically equivalent) | September 21, 2017 | 15MG, 30MG |
| CHARTWELL MOLECULAR HOLDINGS LLC | 207156 | AB (A-rated, therapeutically equivalent) | September 28, 2017 | 15MG, 30MG |
| ZYDUS PHARMACEUTICALS USA INC | 200816 | AB (A-rated, therapeutically equivalent) | November 27, 2018 | 15MG, 30MG |
| MYLAN PHARMACEUTICALS INC | 202396 | AB (A-rated, therapeutically equivalent) | November 28, 2018 | 15MG, 30MG |
| ALKEM LABORATORIES LTD | 207394 | AB (A-rated, therapeutically equivalent) | January 18, 2019 | 15MG, 30MG |
| HETERO LABS LTD UNIT III | 203083 | AB (A-rated, therapeutically equivalent) | May 18, 2020 | 15MG, 30MG |
| DR REDDYS LABORATORIES LTD | 210465 | AB (A-rated, therapeutically equivalent) | February 1, 2021 | 15MG, 30MG |
| AUROBINDO PHARMA LTD | 207167 | AB (A-rated, therapeutically equivalent) | March 28, 2023 | 15MG, 30MG |
Prevacid NDC codes
Questions
Is there a generic for Prevacid?
Yes. The generic name for Prevacid is lansoprazole. 13 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 Prevacid products the Orange Book lists.
What is the generic name for Prevacid?
The active ingredient in Prevacid is lansoprazole, 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.