FDA.reportPublic FDA data

NDC 80425-0111-01 - Esomeprazole Magnesium DR

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
80425-0111
Requested NDC
80425-0111-01
Package NDCs from labels
80425-0111-1, 80425-0111-2, 80425-0111-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Esomeprazole Magnesium DR - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0111-1Esomeprazole MagnesiumDR30 in 1 BOTTLECAPSULE, DELAYED RELEASE307
80425-0111-2Esomeprazole MagnesiumDR60 in 1 BOTTLECAPSULE, DELAYED RELEASE607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0111ESOMEPRAZOLE MAGNESIUM DR (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 2 package rows20250101_b4cd8ed1-d9d1-5b57-e053-2995a90a9f3c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0111-1EA - Each80425-01113e6f84d4-e7ba-4e3a-bd57-e7977538a56712023-04-07
80425-0111-2EA - Each80425-0111757b17d7-2777-405b-bd39-e6ddf04789e812023-04-07

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 9 of 10 · 186 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMAscend Laboratories, LLCf3d4a0d7-77fd-496e-8dfa-2b2dbace4bac2024-02-29Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMMedsource Pharmaceuticals1278cf6f-cc7a-462b-e063-6394a90a34e52024-02-28Warnings, Adverse reactionsExact identifier
rxcui: 606726
basic care esomeprazole magnesiumESOMEPRAZOLEAmazon.com Services LLC2466913b-7292-4dfd-8ac9-429256faacee2024-02-13WarningsExact identifier
rxcui: 606726
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMProficient Rx LP7b92ac4f-50c9-4061-b4a7-535a58cea8f62024-02-01Warnings, Adverse reactionsExact identifier
rxcui: 606730
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMZhejiang Yongtai Pharmaceutical Co., Ltd5ea93b2b-115b-4591-97ea-311d77e3a5ba2024-01-09Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMSolco Healthcare US LLC3cd80c04-43a2-4be3-b831-ebccc273a0d22023-12-28Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutions71956762-d2f7-4763-9afe-1ca8f32a3cbb2023-12-27Warnings, Adverse reactionsExact identifier
rxcui: 606730
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutions99fceec8-59a2-485f-a7f3-7c5afd98401d2023-12-27Warnings, Adverse reactionsExact identifier
rxcui: 606730
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMGlenmark Pharmaceuticals Inc., USAa6430045-ae60-4a16-92b9-2975cb4976292023-12-07Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMTIME CAP LABORATORIES, INC.08acf79f-f50d-8416-e063-6294a90a27042023-11-23WarningsExact identifier
rxcui: 606726
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMBETTER LIVING BRANDS, LLCeb4c1cac-89a2-c040-e053-2995a90ae1cd2023-11-17WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMMylan Pharmaceuticals Inc.e04e7c84-59c8-4a1d-8dfc-d72588b97b592023-11-15Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
EsomeprazoleESOMEPRAZOLE MAGNESIUMVALU MERCHANDISERS COMPANYab83bbdd-2c8e-46bd-b39e-69199e004be42023-11-03WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutionsdef3f166-e740-41ed-82c0-9b03dd6432b12023-11-02Warnings, Adverse reactionsExact identifier
rxcui: 606730
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutionse79725fe-54c8-4dcb-a03a-0c91cc20cf772023-10-31Warnings, Adverse reactionsExact identifier
rxcui: 606726
EsomeprazoleESOMEPRAZOLESafeway, Inc.7c497204-29ce-45e0-84d4-91b981c9b7aa2023-08-25WarningsExact identifier
rxcui: 606726
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMZydus Pharmaceuticals USA Inc.190a4c5b-1547-45d7-b00b-10da4131e2e22023-08-17Warnings, Adverse reactionsExact identifier
unii: 36H71644EQ
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Inc15023261-51c8-2388-3439-48dace49ec022023-07-25Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMNorthStar Rx LLC380da8db-bfa3-8c0c-f8f3-573675fed9812023-07-15Warnings, Adverse reactionsExact identifier
rxcui: 606726
rxcui: 606730
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMGLENMARK THERAPEUTICS INC., USAff233fbb-716d-4879-811c-c8d82e3c99ce2023-05-25Exact identifier
rxcui: 606726

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.