Norethindrone acetate
Norethindrone acetate tablets, USP Rx only
Approved
Approval ID
2f39b608-cc62-4ff0-a52a-bc3343275269
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 4, 2023
Manufacturers
FDA
Ingenus Pharmaceuticals, LLC
DUNS: 833250017
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
norethindrone acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50742-267
Application NumberANDA206490
Product Classification
M
Marketing Category
C73584
G
Generic Name
norethindrone acetate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 29, 2019
FDA Product Classification
INGREDIENTS (4)
NORETHINDRONE ACETATEActive
Quantity: 5 mg in 1 1
Code: 9S44LIC7OJ
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT