Esomeprazole Magnesium
Esomeprazole Magnesium DR 20mg Capsules
Approved
Approval ID
b4cd8ed1-d9d1-5b57-e053-2995a90a9f3c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2022
Manufacturers
FDA
Advanced Rx Pharmacy of Tennessee, LLC
DUNS: 117023142
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Esomeprazole Magnesium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code80425-0111
Application NumberANDA205606
Product Classification
M
Marketing Category
C73584
G
Generic Name
Esomeprazole Magnesium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 17, 2022
FDA Product Classification
INGREDIENTS (1)
ESOMEPRAZOLE MAGNESIUM DIHYDRATEActive
Quantity: 20 mg in 1 1
Code: 36H71644EQ
Classification: ACTIM