Home NDC 59651-803 Esomeprazole Magnesium
Product NDC 59651-803
11-digit product format 596510803
Labeler code 59651
Product ID 59651-803_3c7a6b13-c67d-48f7-b170-1437a420d704
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Esomeprazole Magnesium
Dosage form GRANULE, DELAYED RELEASE
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA219213
Marketing category ANDA
Marketing start 2025-04-15
Substance ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
Active strength 10 mg/1
Pharmacologic classes Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219213-001 ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 10MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-04-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219213-001 AB
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.
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 2026-10-15 13:18:30 2026-09 A219213-001 ESOMEPRAZOLE MAGNESIUM EQ 10MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-04-15 c2088c7a36db…2026-09-14 22:38:34 2026-08 A219213-001 ESOMEPRAZOLE MAGNESIUM EQ 10MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-04-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219213-001 ESOMEPRAZOLE MAGNESIUM EQ 10MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-04-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219213-001 ESOMEPRAZOLE MAGNESIUM EQ 10MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-04-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219213-001 ESOMEPRAZOLE MAGNESIUM EQ 10MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-04-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219213-001 ESOMEPRAZOLE MAGNESIUM EQ 10MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-04-15 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219213-001 ESOMEPRAZOLE MAGNESIUM EQ 10MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-04-15 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Esomeprazole Magnesium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESOMEPRAZOLE MAGNESIUM TRIHYDRATE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R6DXU4WAY9 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861568 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 59651-803-30 Esomeprazole Magnesium 30 in 1 CARTON GRANULE, DELAYED RELEASE 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-803 ESOMEPRAZOLE MAGNESIUM GRANULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED] 1 Current NDC, 1 package rows 20250426_3c7a6b13-c67d-48f7-b170-1437a420d704.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 Marketing start Sample Exclude flag Status 59651-803-30 59651080330 30 GRANULE, DELAYED RELEASE in 1 CARTON (59651-803-30) 2025-04-15 No No Current