Norethindrone Acetate and Ethinyl Estradiol
These highlights do not include all the information needed to use NORETHINDRONE ACETATE and ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORETHINDRONE ACETATE and ETHINYL ESTRADIOL TABLETS. Norethindrone Acetate and Ethinyl Estradiol Tablets USP, for Oral Use Initial U.S. Approval: 1968
Approved
Approval ID
2c2a37e1-adaf-4947-abb1-736bfa58bf98
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 24, 2023
Manufacturers
FDA
Nivagen Pharmaceuticals, Inc.
DUNS: 052032418
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Norethindrone Acetate and Ethinyl Estradiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75834-129
Application NumberANDA203435
Product Classification
M
Marketing Category
C73584
G
Generic Name
Norethindrone Acetate and Ethinyl Estradiol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 22, 2022
FDA Product Classification
INGREDIENTS (14)
Norethindrone AcetateActive
Quantity: 0.5 mg in 1 1
Code: 9S44LIC7OJ
Classification: ACTIB
Ethinyl EstradiolActive
Quantity: 0.0025 mg in 1 1
Code: 423D2T571U
Classification: ACTIB
Lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)Inactive
Code: 8136Y38GY5
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Polyvinyl Alcohol, UnspecifiedInactive
Code: 532B59J990
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
Norethindrone Acetate and Ethinyl Estradiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75834-130
Application NumberANDA203435
Product Classification
M
Marketing Category
C73584
G
Generic Name
Norethindrone Acetate and Ethinyl Estradiol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 22, 2022
FDA Product Classification
INGREDIENTS (12)
Norethindrone AcetateActive
Quantity: 1 mg in 1 1
Code: 9S44LIC7OJ
Classification: ACTIB
Lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Ethinyl EstradiolActive
Quantity: 0.005 mg in 1 1
Code: 423D2T571U
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)Inactive
Code: 8136Y38GY5
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
PolydextroseInactive
Code: VH2XOU12IE
Classification: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
TriacetinInactive
Code: XHX3C3X673
Classification: IACT