Norethindrone Acetate
Norethindrone Acetate Tablets, USP Rx Only
Approved
Approval ID
827c7ef1-a8b7-d0c4-b062-c5154b331a35
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
Manufacturers
FDA
AvKARE
DUNS: 796560394
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Norethindrone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42291-650
Application NumberANDA200275
Product Classification
M
Marketing Category
C73584
G
Generic Name
Norethindrone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2024
FDA Product Classification
INGREDIENTS (4)
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
NORETHINDRONE ACETATEActive
Quantity: 5 mg in 1 1
Code: 9S44LIC7OJ
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT