Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
zaleplon
Product Details
NDC Product Code
29300-131Application Number
ANDA078989Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 28, 2021FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1MClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
ZaleplonActive
Code: S62U433RMHClass: ACTIBQuantity: 5 mg in 1 1
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
zaleplon
Product Details
NDC Product Code
29300-132Application Number
ANDA078989Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 28, 2021CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
ZaleplonActive
Code: S62U433RMHClass: ACTIBQuantity: 10 mg in 1 1
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT