Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
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
62abde41-46cb-4e90-a798-23d6531bf9aa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2024
Manufacturers
FDA
SpecGx LLC
DUNS: 080679498
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0406-8005
Application NumberANDA207000
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateJanuary 3, 2024
FDA Product Classification
INGREDIENTS (13)
BUPRENORPHINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: 56W8MW3EN1
Classification: ACTIM
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
NALOXONE HYDROCHLORIDE DIHYDRATEActive
Quantity: 0.5 mg in 1 1
Code: 5Q187997EE
Classification: ACTIM
Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0406-8020
Application NumberANDA207000
Product Classification
M
Marketing Category
C73584
G
Generic Name
Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateJanuary 3, 2024
FDA Product Classification
INGREDIENTS (13)
BUPRENORPHINE HYDROCHLORIDEActive
Quantity: 8 mg in 1 1
Code: 56W8MW3EN1
Classification: ACTIM
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
NALOXONE HYDROCHLORIDE DIHYDRATEActive
Quantity: 2 mg in 1 1
Code: 5Q187997EE
Classification: ACTIM