Buprenorphine and Naloxone
These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM. BUPRENORPHINE and NALOXONE sublingual film, for sublingual or buccal use CIII Initial U.S. Approval: 2002
Approved
Approval ID
718756d7-0131-b173-6c45-5ee039b311b0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Dr.Reddys Laboratories Inc
DUNS: 802315887
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Buprenorphine and Naloxone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-582
Application NumberANDA205299
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buprenorphine and Naloxone
Product Specifications
Route of AdministrationBUCCAL, SUBLINGUAL
Effective DateNovember 5, 2019
FDA Product Classification
INGREDIENTS (15)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
BUPRENORPHINE HYDROCHLORIDEActive
Quantity: 8 mg in 1 1
Code: 56W8MW3EN1
Classification: ACTIM
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
NaloxoneActive
Quantity: 2 mg in 1 1
Code: 36B82AMQ7N
Classification: ACTIB
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MALTITOLInactive
Code: D65DG142WK
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQ
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
Buprenorphine and Naloxone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-579
Application NumberANDA205299
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buprenorphine and Naloxone
Product Specifications
Route of AdministrationBUCCAL, SUBLINGUAL
Effective DateNovember 5, 2019
FDA Product Classification
INGREDIENTS (15)
BUPRENORPHINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: 56W8MW3EN1
Classification: ACTIM
NaloxoneActive
Quantity: 0.5 mg in 1 1
Code: 36B82AMQ7N
Classification: ACTIB
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MALTITOLInactive
Code: D65DG142WK
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT