ESOMEPRAZOLE MAGNESIUM
1173 ESOMEPRAZOLE MG DR 40MG
Approved
Approval ID
874e4e49-ff3b-0e1b-e053-2a95a90af2ec
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2019
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
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 Code76519-1173
Application NumberANDA078279
Product Classification
M
Marketing Category
C73584
G
Generic Name
ESOMEPRAZOLE MAGNESIUM
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2019
FDA Product Classification
INGREDIENTS (1)
ESOMEPRAZOLE MAGNESIUMActive
Quantity: 40 mg in 1 1
Code: R6DXU4WAY9
Classification: ACTIM