Naproxen
Approved
Approval ID
bc2c6b1e-999d-91a7-e053-2a95a90a9d1a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 25, 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.
Naproxen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code80175-0436
Application NumberANDA212517
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 25, 2021
FDA Product Classification
INGREDIENTS (1)
NAPROXENActive
Quantity: 500 mg in 1 1
Code: 57Y76R9ATQ
Classification: ACTIB