Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
XSPIRE PHARMA
Xspire Pharma, Llc
078312042
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TaperDex 6-day
Product Details
NDC Product Code
42195-121Application Number
ANDA088237Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 18, 2022DexamethasoneActive
Code: 7S5I7G3JQLClass: ACTIBQuantity: 1.5 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
TaperDex 6-day
Product Details
NDC Product Code
42195-221Application Number
ANDA088237Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 18, 2022DexamethasoneActive
Code: 7S5I7G3JQLClass: ACTIBQuantity: 1.5 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT