Home NDC 68083-452-01 NDC 68083-452-01 - Esomeprazole Sodium This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
Product NDC 68083-452
Requested NDC 68083-452-01
Package NDCs from labels 68083-452-01, 68083-452-10
Manufacturer Gland Pharma Limited
Effective date 2023-07-21
Current FDA listing Not matched in FDA.report NDC product tables DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68083-452-01 Esomeprazole Sodium 5 mL in 1 VIAL INJECTION 5 7 68083-452-10 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 68083-452 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 ยท 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Esomeprazole sodium ESOMEPRAZOLE SODIUM Slate Run Pharmaceuticals, LLC 23395673-116d-4a8e-b0ce-59f9ca5b3daf 2026-06-22 Warnings, Adverse reactions Exact identifier rxcui: 486501 unii: L2C9GWQ43H Esomeprazole Sodium ESOMEPRAZOLE SODIUM Eugia US LLC 45a15ba2-2aae-4edc-beaa-4a2357d87f32 2025-11-07 Warnings, Adverse reactions Exact identifier rxcui: 486501 unii: L2C9GWQ43H Esomeprazole Sodium ESOMEPRAZOLE SODIUM Gland Pharma Limited 9354958c-e997-41c8-8605-23f0a58993c0 2023-07-21 Warnings, Adverse reactions Exact identifier application number: ANDA203349 ndc (package): 68083-451-10 ndc (package): 68083-452-01 ndc (package): 68083-451-01 ndc (package): 68083-452-10 ndc (product): 68083-452 ndc (product): 68083-451 ndc11 (package): 68083045201 rxcui: 486499 rxcui: 486501 spl id: e8d62781-b9de-4d02-b5d2-02b024895c95 spl set id: 9354958c-e997-41c8-8605-23f0a58993c0 unii: L2C9GWQ43H Miracle FootCream Lavender UREA, GLYCERIN, ALOE, DISODIUM EDTA Aloe Vera Korea Co.,Ltd. db520c80-2a2a-5eb1-e053-2995a90a5bb4 2022-03-28 Warnings Exact identifier unii: 7FLD91C86K Miracle FootCream Lemon UREA, GLYCERIN, ALOE, DISODIUM EDTA Aloe Vera Korea Co.,Ltd. db525c63-29fd-2033-e053-2995a90a56b9 2022-03-28 Warnings Exact identifier unii: 7FLD91C86K
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.