FDA Orange Book
Generic for Nexium IV
Nexium IV 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 IV is esomeprazole. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Nexium IV products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, intravenous | EQ 20MG BASE/VIAL | Discontinued | None | 1 | None |
| injectable, intravenous | EQ 40MG BASE/VIAL | Discontinued | None | 4 | AP |
NDA 021689, 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 |
|---|---|---|---|---|
| REGCON HOLDINGS LLC | 207181 | AP (A-rated, therapeutically equivalent) | March 6, 2017 | EQ 40MG BASE/VIAL |
| GLAND PHARMA LTD | 203349 | None (No TE code listed) | April 1, 2020 | EQ 20MG BASE/VIAL, EQ 40MG BASE/VIAL |
| HAINAN POLY PHARM CO LTD | 215732 | AP (A-rated, therapeutically equivalent) | February 10, 2022 | EQ 40MG BASE/VIAL |
| EPIC PHARMA LLC | 214046 | AP (A-rated, therapeutically equivalent) | January 8, 2025 | EQ 40MG BASE/VIAL |
Questions
Is there a generic for Nexium IV?
Yes. The generic name for Nexium IV is esomeprazole. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Nexium IV?
The active ingredient in Nexium IV 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.