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, for sublingual administration CIII Initial U.S. Approval: 2002
Approved
Approval ID
35d29e9b-9950-452a-a795-5a7514f0edfd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 3, 2023
Manufacturers
FDA
Accord Healthcare, Inc
DUNS: 604222237
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 Code16729-550
Application NumberANDA209069
Product Classification
M
Marketing Category
C73584
G
Generic Name
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateMay 3, 2023
FDA Product Classification
INGREDIENTS (11)
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
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
NALOXONE HYDROCHLORIDE DIHYDRATEActive
Quantity: 2 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 Code16729-549
Application NumberANDA209069
Product Classification
M
Marketing Category
C73584
G
Generic Name
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateMay 3, 2023
FDA Product Classification
INGREDIENTS (11)
BUPRENORPHINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: 56W8MW3EN1
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
NALOXONE HYDROCHLORIDE DIHYDRATEActive
Quantity: 0.5 mg in 1 1
Code: 5Q187997EE
Classification: ACTIM