Buprenorphine and Naloxone
These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002
Approved
Approval ID
91b68606-05de-4586-ae31-07e8cc9160cf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 6, 2023
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
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 Code62756-970
Application NumberANDA201633
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buprenorphine and Naloxone
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateNovember 6, 2023
FDA Product Classification
INGREDIENTS (12)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
BUPRENORPHINE HYDROCHLORIDEActive
Quantity: 8 mg in 1 1
Code: 56W8MW3EN1
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
NALOXONE HYDROCHLORIDE DIHYDRATEActive
Quantity: 2 mg in 1 1
Code: 5Q187997EE
Classification: ACTIM
Buprenorphine and Naloxone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62756-969
Application NumberANDA201633
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buprenorphine and Naloxone
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateNovember 6, 2023
FDA Product Classification
INGREDIENTS (12)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
BUPRENORPHINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: 56W8MW3EN1
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
NALOXONE HYDROCHLORIDE DIHYDRATEActive
Quantity: 0.5 mg in 1 1
Code: 5Q187997EE
Classification: ACTIM