Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Terbutaline Sulfate
Product Details
NDC Product Code
10135-579Application Number
ANDA077152Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 6, 2020TerbutalineActive
Code: 576PU70Y8EClass: ACTIBQuantity: 2.5 mg in 1 1
POVIDONEInactive
Code: FZ989GH94EClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Terbutaline Sulfate
Product Details
NDC Product Code
10135-580Application Number
ANDA077152Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 6, 2020TerbutalineActive
Code: 576PU70Y8EClass: ACTIBQuantity: 5 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT