Products5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
FENTORA
Product Details
NDC Product Code
63459-541Application Number
NDA021947Marketing Category
NDA (C73594)Route of Administration
BUCCAL, SUBLINGUALEffective Date
December 17, 2023FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 100 ug in 1 1
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7TClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FENTORA
Product Details
NDC Product Code
63459-548Application Number
NDA021947Marketing Category
NDA (C73594)Route of Administration
BUCCAL, SUBLINGUALEffective Date
December 17, 2023FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 800 ug in 1 1
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7TClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FENTORA
Product Details
NDC Product Code
63459-544Application Number
NDA021947Marketing Category
NDA (C73594)Route of Administration
BUCCAL, SUBLINGUALEffective Date
December 17, 2023FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 400 ug in 1 1
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7TClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FENTORA
Product Details
NDC Product Code
63459-542Application Number
NDA021947Marketing Category
NDA (C73594)Route of Administration
BUCCAL, SUBLINGUALEffective Date
December 17, 2023FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 200 ug in 1 1
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7TClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FENTORA
Product Details
NDC Product Code
63459-546Application Number
NDA021947Marketing Category
NDA (C73594)Route of Administration
BUCCAL, SUBLINGUALEffective Date
December 17, 2023SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7TClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 600 ug in 1 1
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT