Home Applications 021689 Application 021689
Type NDA
Sponsor ASTRAZENECA PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NEXIUM IV ESOMEPRAZOLE SODIUM INJECTABLE;INTRAVENOUS EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 002 NEXIUM IV ESOMEPRAZOLE SODIUM INJECTABLE;INTRAVENOUS EQ 40MG BASE/VIAL Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021689-001 NEXIUM IV ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-03-31 N021689-002 NEXIUM IV ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-03-31
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021689-001 NEXIUM IV EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-03-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021689-002 NEXIUM IV EQ 40MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-03-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021689-001 NEXIUM IV EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-03-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021689-002 NEXIUM IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS RLD 2005-03-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021689-001 NEXIUM IV EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-03-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021689-002 NEXIUM IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS RLD 2005-03-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021689-001 NEXIUM IV EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-03-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021689-002 NEXIUM IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS RLD 2005-03-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021689-001 NEXIUM IV EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-03-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021689-002 NEXIUM IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS RLD 2005-03-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021689-001 NEXIUM IV EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-03-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021689-002 NEXIUM IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS RLD 2005-03-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021689-001 NEXIUM IV EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-03-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021689-002 NEXIUM IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS RLD 2005-03-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021689-001 NEXIUM IV EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-03-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021689-002 NEXIUM IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS RLD 2005-03-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021689-001 NEXIUM IV EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-03-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021689-002 NEXIUM IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS RLD 2005-03-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021689-001 NEXIUM IV EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-03-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021689-002 NEXIUM IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS RLD 2005-03-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021689-001 NEXIUM IV EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-03-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021689-002 NEXIUM IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021689-001 NEXIUM IV EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-03-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021689-002 NEXIUM IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021689-001 NEXIUM IV EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-03-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021689-002 NEXIUM IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021689-001 NEXIUM IV EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-03-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021689-002 NEXIUM IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021689-001 NEXIUM IV EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-03-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021689-002 NEXIUM IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021689-001 NEXIUM IV EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RLD 2005-03-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021689-002 NEXIUM IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021689-001 NEXIUM IV EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RLD 2005-03-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021689-002 NEXIUM IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021689-001 NEXIUM IV EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INTRAVENOUS RLD 2005-03-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021689-002 NEXIUM IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021689-001 NEXIUM IV EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-03-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021689-002 NEXIUM IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021689-001 NEXIUM IV EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INTRAVENOUS RLD 2005-03-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021689-002 NEXIUM IV EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-31 782e0a99824c…
Observed Orange Book normalized TE history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0186-6020 NEXIUM Esomeprazole sodium AstraZeneca Pharmaceuticals LP NDA Current 0186-6040 NEXIUM Esomeprazole sodium AstraZeneca Pharmaceuticals LP NDA Current 0186-6040 NEXIUM Esomeprazole sodium AstraZeneca Pharmaceuticals LP NDA Current 0186-6040 NEXIUM Esomeprazole sodium AstraZeneca Pharmaceuticals LP NDA Current 0186-6040 NEXIUM Esomeprazole sodium AstraZeneca Pharmaceuticals LP NDA Current