Home NDC 68083-451 Esomeprazole Sodium
Product NDC 68083-451
11-digit product format 680830451
Labeler code 68083
Product ID 68083-451_e8d62781-b9de-4d02-b5d2-02b024895c95
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Esomeprazole Sodium
Dosage form INJECTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA203349
Marketing category ANDA
Marketing start 2020-04-01
Substance ESOMEPRAZOLE SODIUM
Active strength 20 mg/5mL
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 A203349-001 ESOMEPRAZOLE SODIUM ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 A203349-002 ESOMEPRAZOLE SODIUM ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203349-002 AP
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 2 · 74 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 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS RS 2020-04-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS 2020-04-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203349-001 ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203349-002 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2020-04-01 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 observed states.
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 20 mg/5mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 486499 Internal RxNorm lookup 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 68083-451-01 Esomeprazole Sodium 5 mL in 1 VIAL INJECTION 5 7 68083-451-10 Esomeprazole Sodium 10 in 1 CARTON INJECTION 10 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-451 ESOMEPRAZOLE SODIUM INJECTION [GLAND PHARMA LIMITED] 7 Current NDC, Legacy NDC, 2 package rows 20230801_9354958c-e997-41c8-8605-23f0a58993c0.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 68083-451-01 68083045101 5 mL in 1 VIAL 5 ml Historical 68083-451-10 68083045110 10 VIAL in 1 CARTON (68083-451-10) / 5 mL in 1 VIAL (68083-451-01) 10 vial 2020-04-01 0000-00-00 No No Current