Products6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ACTIQ
Product Details
NDC Product Code
63459-504Application Number
NDA020747Marketing Category
NDA (C73594)Route of Administration
ORAL, TRANSMUCOSALEffective Date
December 18, 2023FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 400 ug in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6FClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6TClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
DEXTRATESInactive
Code: G263MI44RUClass: IACT
ACTIQ
Product Details
NDC Product Code
63459-506Application Number
NDA020747Marketing Category
NDA (C73594)Route of Administration
ORAL, TRANSMUCOSALEffective Date
December 18, 2023DEXTRATESInactive
Code: G263MI44RUClass: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6FClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6TClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 600 ug in 1 1
ACTIQ
Product Details
NDC Product Code
63459-512Application Number
NDA020747Marketing Category
NDA (C73594)Route of Administration
ORAL, TRANSMUCOSALEffective Date
December 18, 2023ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 1200 ug in 1 1
DEXTRATESInactive
Code: G263MI44RUClass: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6FClass: IACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6TClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ACTIQ
Product Details
NDC Product Code
63459-516Application Number
NDA020747Marketing Category
NDA (C73594)Route of Administration
ORAL, TRANSMUCOSALEffective Date
December 18, 2023FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 1600 ug in 1 1
DEXTRATESInactive
Code: G263MI44RUClass: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6FClass: IACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6TClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ACTIQ
Product Details
NDC Product Code
63459-508Application Number
NDA020747Marketing Category
NDA (C73594)Route of Administration
ORAL, TRANSMUCOSALEffective Date
December 18, 2023SUCROSEInactive
Code: C151H8M554Class: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 800 ug in 1 1
DEXTRATESInactive
Code: G263MI44RUClass: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6FClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6TClass: IACT
ACTIQ
Product Details
NDC Product Code
63459-502Application Number
NDA020747Marketing Category
NDA (C73594)Route of Administration
ORAL, TRANSMUCOSALEffective Date
December 18, 2023MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6TClass: IACT
FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 200 ug in 1 1
DEXTRATESInactive
Code: G263MI44RUClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6FClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT