Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Everolimus
Product Details
NDC Product Code
0378-0005Application Number
ANDA210130Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 10, 2022MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
EverolimusActive
Code: 9HW64Q8G6GClass: ACTIBQuantity: 2 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693YClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Everolimus
Product Details
NDC Product Code
0378-0006Application Number
ANDA210130Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 10, 2022EverolimusActive
Code: 9HW64Q8G6GClass: ACTIBQuantity: 3 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693YClass: IACT
Everolimus
Product Details
NDC Product Code
0378-0007Application Number
ANDA210130Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 10, 2022HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693YClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
EverolimusActive
Code: 9HW64Q8G6GClass: ACTIBQuantity: 5 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT