NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
-906780-307848000Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg
Approved
Approval ID
89948751-bd6e-4e9c-b87c-8782706c1097
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 15, 2024
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 1
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 Code0378-7280
Application NumberANDA202771
Product Classification
M
Marketing Category
C73584
G
Generic Name
norethindrone acetate and ethinyl estradiol
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 6, 2017
FDA Product Classification
INGREDIENTS (10)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ETHINYL ESTRADIOLActive
Quantity: 0.02 mg in 1 1
Code: 423D2T571U
Classification: ACTIB
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01
Classification: IACT
NORETHINDRONE ACETATEActive
Quantity: 1 mg in 1 1
Code: 9S44LIC7OJ
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT