Omeprazole
Approved
Approval ID
bc1d591a-3835-e251-e053-2a95a90aab89
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 24, 2021
Manufacturers
FDA
Central Packaging
DUNS: 117617671
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Omeprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code80175-0715
Application NumberANDA075576
Product Classification
M
Marketing Category
C73584
G
Generic Name
Omeprazole
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 24, 2021
FDA Product Classification
INGREDIENTS (1)
OMEPRAZOLEActive
Quantity: 20 mg in 1 1
Code: KG60484QX9
Classification: ACTIB