Norethindrone Acetate and Ethinyl Estradiol
Norethindrone Acetate and Ethinyl Estradiol Tablets, USP 1 mg/ 0.02 mg Rx only
Approved
Approval ID
5a44f7a2-45f1-4d28-b9fb-61d9f2456422
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 3, 2023
Manufacturers
FDA
Glenmark Pharmaceuticals Inc., USA
DUNS: 130597813
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 Code68462-132
Application NumberANDA206969
Product Classification
M
Marketing Category
C73584
G
Generic Name
Norethindrone Acetate and Ethinyl Estradiol
Product Specifications
Route of AdministrationORAL
Effective DateJune 22, 2022
FDA Product Classification
INGREDIENTS (8)
NORETHINDRONE ACETATEActive
Quantity: 1 mg in 1 1
Code: 9S44LIC7OJ
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ETHINYL ESTRADIOLActive
Quantity: 0.02 mg in 1 1
Code: 423D2T571U
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT