Home NDC 55150-185 Esomeprazole Sodium
Product NDC 55150-185
11-digit product format 551500185
Labeler code 55150
Product ID 55150-185_0f4cf0d6-61e7-429c-8658-e885e3c09b4a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Esomeprazole Sodium
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Eugia US LLC
Application ANDA204657
Marketing category ANDA
Marketing start 2016-08-10
Substance ESOMEPRAZOLE SODIUM
Active strength 40 mg/1
Pharmacologic classes Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing 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 A204657-001 ESOMEPRAZOLE SODIUM ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS 2016-08-10 A204657-002 ESOMEPRAZOLE SODIUM ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS 2016-08-10
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 A204657-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS 2016-08-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204657-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS 2016-08-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204657-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS 2016-08-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204657-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS 2016-08-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204657-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS 2016-08-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204657-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS 2016-08-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204657-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS 2016-08-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204657-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2016-08-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204657-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS 2016-08-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204657-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2016-08-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204657-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS 2016-08-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204657-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2016-08-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204657-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS 2016-08-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204657-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2016-08-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204657-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS 2016-08-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204657-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2016-08-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204657-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS 2016-08-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204657-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2016-08-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204657-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS 2016-08-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204657-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2016-08-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204657-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS 2016-08-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204657-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2016-08-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204657-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS 2016-08-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204657-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2016-08-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204657-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS 2016-08-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204657-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2016-08-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204657-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS 2016-08-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204657-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2016-08-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204657-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS 2016-08-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204657-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RS 2016-08-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204657-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS 2016-08-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204657-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RS 2016-08-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204657-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS 2016-08-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204657-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RS 2016-08-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204657-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS 2016-08-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204657-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RS 2016-08-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204657-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS 2016-08-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204657-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RS 2016-08-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204657-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS 2016-08-10 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A204657-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RS 2016-08-10 782e0a99824c…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Esomeprazole Sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESOMEPRAZOLE SODIUM 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L2C9GWQ43H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 486501 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55150-185-05 Esomeprazole Sodium 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 12 55150-185-05 Esomeprazole Sodium 1 in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-185 ESOMEPRAZOLE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC] 11 Current NDC, Legacy NDC, 2 package rows 20240829_45a15ba2-2aae-4edc-beaa-4a2357d87f32.zip
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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55150-185-05 55150018505 10 VIAL in 1 CARTON (55150-185-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL 10 vial 2016-08-10 0000-00-00 No No Current