Home NDC 21130-718 Esomeprazole magnesium
Product NDC 21130-718
11-digit product format 211300718
Labeler code 21130
Product ID 21130-718_0a55d8b3-0539-2e0d-e063-6294a90a92a4
Type HUMAN OTC DRUG
Nonproprietary name esomeprazole magnesium
Dosage form CAPSULE, DELAYED RELEASE
Route ORAL
Labeler BETTER LIVING BRANDS, LLC
Application ANDA217264
Marketing category ANDA
Marketing start 2023-10-20
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 42 .
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 2026-08-18 06:07:40 2026-07 A217264-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-09-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217264-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-09-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217264-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-09-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217264-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-09-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217264-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-09-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217264-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-09-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217264-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-09-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217264-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-09-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217264-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-09-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217264-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-09-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217264-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-09-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217264-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-09-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217264-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-09-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217264-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-09-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217264-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-09-29 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217264-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-09-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217264-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-09-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217264-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-09-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217264-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-09-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217264-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-09-29 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217264-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-09-29 a50c72e98297…
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 21130-718-41 Esomeprazole magnesium 14 in 1 BOTTLE CAPSULE, DELAYED RELEASE 14 4 21130-718-41 Esomeprazole magnesium 3 in 1 CARTON CAPSULE, DELAYED RELEASE 3 4 21130-718-45 Esomeprazole magnesium 1 in 1 CARTON CAPSULE, DELAYED RELEASE 1 4 21130-718-45 Esomeprazole magnesium 14 in 1 BOTTLE CAPSULE, DELAYED RELEASE 14 4 21130-718-82 Esomeprazole magnesium 14 in 1 CARTON CAPSULE, DELAYED RELEASE 14 4 21130-718-82 Esomeprazole magnesium 2 in 1 CARTON CAPSULE, DELAYED RELEASE 2 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21130-718 ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [BETTER LIVING BRANDS, LLC] 4 Current NDC, 6 package rows 20231118_eb4c1cac-89a2-c040-e053-2995a90ae1cd.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 · 9 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 21130-718-41 21130071841 3 BOTTLE in 1 CARTON (21130-718-41) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 3 bottle 2023-10-20 No No Current 21130-718-45 21130071845 1 BOTTLE in 1 CARTON (21130-718-45) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 1 bottle 2023-10-20 No No Current 21130-718-82 21130071882 2 CARTON in 1 CARTON (21130-718-82) / 14 CAPSULE, DELAYED RELEASE in 1 CARTON 2 carton 2023-11-13 No No Current