Suboxone
These highlights do not include all the information needed to use SUBOXONE sublingual film safely and effectively. See full prescribing information for SUBOXONE sublingual film.SUBOXONE (buprenorphine and naloxone) sublingual film, for sublingual or buccal use, CIIIInitial U.S. Approval: 2002
Approved
Approval ID
8a5edcf9-828c-4f97-b671-268ab13a8ecd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2023
Manufacturers
FDA
INDIVIOR INC.
DUNS: 797408549
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
buprenorphine hydrochloride, naloxone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code12496-1208
Application NumberNDA022410
Product Classification
M
Marketing Category
C73594
G
Generic Name
buprenorphine hydrochloride, naloxone hydrochloride
Product Specifications
Route of AdministrationSUBLINGUAL, BUCCAL
Effective DateJune 1, 2022
FDA Product Classification
INGREDIENTS (9)
buprenorphine hydrochlorideActive
Quantity: 8 mg in 1 1
Code: 56W8MW3EN1
Classification: ACTIM
naloxone hydrochlorideActive
Quantity: 2 mg in 1 1
Code: F850569PQR
Classification: ACTIM
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
maltitolInactive
Code: D65DG142WK
Classification: IACT
acesulfame potassiumInactive
Code: 23OV73Q5G9
Classification: IACT
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
sodium citrateInactive
Code: 1Q73Q2JULR
Classification: IACT
FD&C yellow no. 6Inactive
Code: H77VEI93A8
Classification: IACT
buprenorphine hydrochloride, naloxone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code12496-1204
Application NumberNDA022410
Product Classification
M
Marketing Category
C73594
G
Generic Name
buprenorphine hydrochloride, naloxone hydrochloride
Product Specifications
Route of AdministrationSUBLINGUAL, BUCCAL
Effective DateJune 1, 2022
FDA Product Classification
INGREDIENTS (9)
buprenorphine hydrochlorideActive
Quantity: 4 mg in 1 1
Code: 56W8MW3EN1
Classification: ACTIM
naloxone hydrochlorideActive
Quantity: 1 mg in 1 1
Code: F850569PQR
Classification: ACTIM
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
acesulfame potassiumInactive
Code: 23OV73Q5G9
Classification: IACT
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
maltitolInactive
Code: D65DG142WK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
sodium citrateInactive
Code: 1Q73Q2JULR
Classification: IACT
FD&C yellow no. 6Inactive
Code: H77VEI93A8
Classification: IACT
buprenorphine hydrochloride, naloxone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code12496-1212
Application NumberNDA022410
Product Classification
M
Marketing Category
C73594
G
Generic Name
buprenorphine hydrochloride, naloxone hydrochloride
Product Specifications
Route of AdministrationSUBLINGUAL, BUCCAL
Effective DateJune 1, 2022
FDA Product Classification
INGREDIENTS (9)
naloxone hydrochlorideActive
Quantity: 3 mg in 1 1
Code: F850569PQR
Classification: ACTIM
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
buprenorphine hydrochlorideActive
Quantity: 12 mg in 1 1
Code: 56W8MW3EN1
Classification: ACTIM
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
maltitolInactive
Code: D65DG142WK
Classification: IACT
acesulfame potassiumInactive
Code: 23OV73Q5G9
Classification: IACT
FD&C yellow no. 6Inactive
Code: H77VEI93A8
Classification: IACT
sodium citrateInactive
Code: 1Q73Q2JULR
Classification: IACT
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
buprenorphine hydrochloride, naloxone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code12496-1202
Application NumberNDA022410
Product Classification
M
Marketing Category
C73594
G
Generic Name
buprenorphine hydrochloride, naloxone hydrochloride
Product Specifications
Route of AdministrationSUBLINGUAL, BUCCAL
Effective DateJune 1, 2022
FDA Product Classification
INGREDIENTS (9)
buprenorphine hydrochlorideActive
Quantity: 2 mg in 1 1
Code: 56W8MW3EN1
Classification: ACTIM
naloxone hydrochlorideActive
Quantity: 0.5 mg in 1 1
Code: F850569PQR
Classification: ACTIM
acesulfame potassiumInactive
Code: 23OV73Q5G9
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
maltitolInactive
Code: D65DG142WK
Classification: IACT
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
FD&C yellow no. 6Inactive
Code: H77VEI93A8
Classification: IACT
sodium citrateInactive
Code: 1Q73Q2JULR
Classification: IACT