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 for sublingual administration CIII Initial U.S. Approval: 2002
Approved
Approval ID
b05b0087-c0ef-40be-9bf3-3933f6cd3492
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 9, 2023
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
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 Code60687-637
Application NumberANDA205601
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buprenorphine and Naloxone
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateMay 9, 2023
FDA Product Classification
INGREDIENTS (14)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CORN SYRUPInactive
Code: 9G5L16BK6N
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
BUPRENORPHINE HYDROCHLORIDEActive
Quantity: 8 mg in 1 1
Code: 56W8MW3EN1
Classification: ACTIM
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 Code60687-626
Application NumberANDA205601
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buprenorphine and Naloxone
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateMay 9, 2023
FDA Product Classification
INGREDIENTS (14)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
CORN SYRUPInactive
Code: 9G5L16BK6N
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
BUPRENORPHINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: 56W8MW3EN1
Classification: ACTIM
NALOXONE HYDROCHLORIDE DIHYDRATEActive
Quantity: 0.5 mg in 1 1
Code: 5Q187997EE
Classification: ACTIM