Norethindrone Acetate
Norethindrone Acetate Tablets USP
Approved
Approval ID
f73f9807-4af6-4faa-ba9a-656a47a4c5e0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2015
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
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 Code0555-0211
Application NumberANDA075951
Product Classification
M
Marketing Category
C73584
G
Generic Name
Norethindrone Acetate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2015
FDA Product Classification
INGREDIENTS (4)
NORETHINDRONE ACETATEActive
Quantity: 5 mg in 1 1
Code: 9S44LIC7OJ
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT