FENTORA
These highlights do not include all the information needed to use FENTORA safely and effectively. See full prescribing information for FENTORA. FENTORA (fentanyl buccal tablet), CIIInitial U.S. Approval: 1968
Approved
Approval ID
8f549d95-985b-f783-1ebb-ef57bd2ecb05
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 17, 2023
Manufacturers
FDA
Cephalon, LLC
DUNS: 183236314
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fentanyl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63459-541
Application NumberNDA021947
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fentanyl
Product Specifications
Route of AdministrationBUCCAL, SUBLINGUAL
Effective DateDecember 17, 2023
FDA Product Classification
INGREDIENTS (7)
FENTANYL CITRATEActive
Quantity: 100 ug in 1 1
Code: MUN5LYG46H
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Fentanyl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63459-548
Application NumberNDA021947
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fentanyl
Product Specifications
Route of AdministrationBUCCAL, SUBLINGUAL
Effective DateDecember 17, 2023
FDA Product Classification
INGREDIENTS (7)
FENTANYL CITRATEActive
Quantity: 800 ug in 1 1
Code: MUN5LYG46H
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Fentanyl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63459-544
Application NumberNDA021947
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fentanyl
Product Specifications
Route of AdministrationBUCCAL, SUBLINGUAL
Effective DateDecember 17, 2023
FDA Product Classification
INGREDIENTS (7)
FENTANYL CITRATEActive
Quantity: 400 ug in 1 1
Code: MUN5LYG46H
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Fentanyl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63459-542
Application NumberNDA021947
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fentanyl
Product Specifications
Route of AdministrationBUCCAL, SUBLINGUAL
Effective DateDecember 17, 2023
FDA Product Classification
INGREDIENTS (7)
FENTANYL CITRATEActive
Quantity: 200 ug in 1 1
Code: MUN5LYG46H
Classification: ACTIM
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Fentanyl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63459-546
Application NumberNDA021947
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fentanyl
Product Specifications
Route of AdministrationBUCCAL, SUBLINGUAL
Effective DateDecember 17, 2023
FDA Product Classification
INGREDIENTS (7)
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FENTANYL CITRATEActive
Quantity: 600 ug in 1 1
Code: MUN5LYG46H
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT