Home NDC 49483-718-41 Esomeprazole magnesium
Product NDC 49483-718
Requested package NDC 49483-718-41
11-digit product format 494830718
Labeler code 49483
Product ID 49483-718_08ad180e-e87a-ba6f-e063-6394a90a2bc7
Type HUMAN OTC DRUG
Nonproprietary name esomeprazole magnesium
Dosage form CAPSULE, DELAYED RELEASE
Route ORAL
Labeler TIME CAP LABORATORIES, INC.
Application ANDA217264
Marketing category ANDA
Marketing start 2023-11-14
Substance ESOMEPRAZOLE MAGNESIUM
Active strength 20 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217264-001 ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-09-29
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 2026-08-01 22:54:32 2026-06 A217264-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-09-29 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 9 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Esomeprazole magnesium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESOMEPRAZOLE MAGNESIUM 20 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 606726 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 49483-718-41 Esomeprazole magnesium 14 in 1 BOTTLE CAPSULE, DELAYED RELEASE 14 1 49483-718-41 Esomeprazole magnesium 3 in 1 CARTON CAPSULE, DELAYED RELEASE 3 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49483-718 ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [TIME CAP LABORATORIES, INC.] 1 Current NDC, 2 package rows 20231123_08acf79f-f50d-8416-e063-6294a90a2704.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 49483-718-41 49483071841 3 BOTTLE in 1 CARTON (49483-718-41) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 3 bottle 2023-11-14 No No Current