NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1.5 mg/0.03 mg
Approved
Approval ID
3108a9bc-3378-459d-8f6b-bd5eff2ad657
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 Code0378-7274
Application NumberANDA202770
Product Classification
M
Marketing Category
C73584
G
Generic Name
norethindrone acetate and ethinyl estradiol
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2018
FDA Product Classification
INGREDIENTS (11)
ETHINYL ESTRADIOLActive
Quantity: 0.03 mg in 1 1
Code: 423D2T571U
Classification: ACTIB
NORETHINDRONE ACETATEActive
Quantity: 1.5 mg in 1 1
Code: 9S44LIC7OJ
Classification: ACTIB
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT