Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Glenmark Pharmaceuticals Limited
Glenmark Pharmaceuticals Inc., USA
677318665
Products1
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
NDC Product Code
68462-132Application Number
ANDA206969Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 22, 2022NorethisteroneActive
Code: 9S44LIC7OJClass: ACTIBQuantity: 1 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
EthinylestradiolActive
Code: 423D2T571UClass: ACTIBQuantity: 0.02 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
ACACIAInactive
Code: 5C5403N26OClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT