FDA Orange Book
Generic for Nexium
Nexium contains esomeprazole. 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 Nexium is esomeprazole. 19 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Nexium products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, delayed rel pellets, oral | EQ 20MG BASE | Marketed (Rx) | AB | 16 | AB |
| capsule, delayed rel pellets, oral | EQ 40MG BASE | Marketed (Rx) | AB | 16 | AB |
| for suspension, delayed release, oral | EQ 10MG BASE/PACKET | Marketed (Rx) | AB | 3 | AB |
| for suspension, delayed release, oral | EQ 2.5MG BASE/PACKET | Marketed (Rx) | AB | 2 | AB |
| for suspension, delayed release, oral | EQ 20MG BASE/PACKET | Marketed (Rx) | AB | 5 | AB |
| for suspension, delayed release, oral | EQ 40MG BASE/PACKET | Marketed (Rx) | AB | 5 | AB |
| for suspension, delayed release, oral | EQ 5MG BASE/PACKET | Marketed (Rx) | AB | 3 | AB |
NDA 021153, 022101, 021957, 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 esomeprazole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 078936 | AB (A-rated, therapeutically equivalent) | August 2, 2015 | EQ 20MG BASE, EQ 40MG BASE |
| DR REDDYS LABORATORIES LTD | 078279 | AB (A-rated, therapeutically equivalent) | September 25, 2015 | EQ 20MG BASE, EQ 40MG BASE |
| AUROBINDO PHARMA LTD | 205606 | AB (A-rated, therapeutically equivalent) | April 21, 2016 | EQ 20MG BASE, EQ 40MG BASE |
| LANNETT CO INC | 205563 | AB (A-rated, therapeutically equivalent) | September 1, 2017 | EQ 20MG BASE, EQ 40MG BASE |
| ALKEM LABORATORIES LTD | 208333 | AB (A-rated, therapeutically equivalent) | October 20, 2017 | EQ 20MG BASE, EQ 40MG BASE |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 209735 | AB (A-rated, therapeutically equivalent) | April 30, 2018 | EQ 20MG BASE, EQ 40MG BASE |
| ZYDUS PHARMACEUTICALS USA INC | 206296 | AB (A-rated, therapeutically equivalent) | May 22, 2019 | EQ 20MG BASE, EQ 40MG BASE |
| CIPLA LTD | 211752 | AB (A-rated, therapeutically equivalent) | March 23, 2020 | EQ 10MG BASE/PACKET |
| CIPLA LTD | 211751 | AB (A-rated, therapeutically equivalent) | March 23, 2020 | EQ 20MG BASE/PACKET, EQ 40MG BASE/PACKET |
| HETERO LABS LTD UNIT III | 211977 | AB (A-rated, therapeutically equivalent) | June 2, 2020 | EQ 20MG BASE, EQ 40MG BASE |
| CSPC OUYI PHARMACEUTICAL CO LTD | 212949 | AB (A-rated, therapeutically equivalent) | October 2, 2020 | EQ 20MG BASE, EQ 40MG BASE |
| GUANGZHOU NOVAKEN PHARM CO LTD | 213859 | AB (A-rated, therapeutically equivalent) | November 18, 2020 | EQ 20MG BASE, EQ 40MG BASE |
| INDCHEMIE HEALTH SPECIALTIES PVT LTD | 210559 | AB (A-rated, therapeutically equivalent) | February 26, 2021 | EQ 20MG BASE, EQ 40MG BASE |
| GRAVITI PHARMACEUTICALS PRIVATE LTD | 213486 | AB (A-rated, therapeutically equivalent) | March 19, 2021 | EQ 20MG BASE, EQ 40MG BASE |
| ETHYPHARM INC | 090841 | AB (A-rated, therapeutically equivalent) | March 31, 2021 | EQ 20MG BASE, EQ 40MG BASE |
| PRINSTON PHARMACEUTICAL INC | 214920 | AB (A-rated, therapeutically equivalent) | March 28, 2023 | EQ 20MG BASE, EQ 40MG BASE |
| ZYDUS PHARMACEUTICALS USA INC | 206055 | AB (A-rated, therapeutically equivalent) | June 7, 2023 | EQ 20MG BASE/PACKET, EQ 40MG BASE/PACKET |
| GRANULES INDIA LTD | 217427 | AB (A-rated, therapeutically equivalent) | October 18, 2023 | EQ 20MG BASE, EQ 40MG BASE |
| ZHEJIANG YONGTAI PHARMACEUTICAL CO LTD | 217022 | AB (A-rated, therapeutically equivalent) | December 27, 2023 | EQ 20MG BASE, EQ 40MG BASE |
| CIPLA LTD | 217714 | AB (A-rated, therapeutically equivalent) | January 7, 2025 | EQ 2.5MG BASE/PACKET, EQ 5MG BASE/PACKET |
| TORRENT PHARMACEUTICALS LTD | 212652 | AB (A-rated, therapeutically equivalent) | March 5, 2025 | EQ 10MG BASE/PACKET |
| TORRENT PHARMACEUTICALS LTD | 212651 | AB (A-rated, therapeutically equivalent) | March 5, 2025 | EQ 2.5MG BASE/PACKET, EQ 20MG BASE/PACKET, EQ 40MG BASE/PACKET, EQ 5MG BASE/PACKET |
| AUROBINDO PHARMA LTD | 219213 | AB (A-rated, therapeutically equivalent) | April 15, 2025 | EQ 10MG BASE/PACKET |
| AUROBINDO PHARMA LTD | 218948 | AB (A-rated, therapeutically equivalent) | April 15, 2025 | EQ 20MG BASE/PACKET, EQ 40MG BASE/PACKET, EQ 5MG BASE/PACKET |
| NOVITIUM PHARMA LLC | 218687 | AB (A-rated, therapeutically equivalent) | September 25, 2026 | EQ 20MG BASE/PACKET, EQ 40MG BASE/PACKET |
Nexium NDC codes
Questions
Is there a generic for Nexium?
Yes. The generic name for Nexium is esomeprazole. 19 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 Nexium?
The active ingredient in Nexium is esomeprazole, 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.
More on Nexium and Esomeprazole
- What is Nexium used for?FDA label uses
- Is Nexium a controlled substance?Federal schedule
- What is Esomeprazole used for?FDA label uses
- Is Esomeprazole a controlled substance?Federal schedule
- Generic for Nexium IVFDA Orange Book
- Proton Pump Inhibitors listFDA drug class
- NDC 0186-4010Nexium NDC record
- NDC 0186-4020Nexium NDC record
- NDC 0186-4025Nexium NDC record