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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

47236a95-ba0b-4f6a-b406-858cabc726df

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 20, 2023

Manufacturers
FDA

Akorn Operating Company LLC (dba Akorn)

DUNS: 117696873

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

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50383-287
Application NumberANDA204431
Product Classification
M
Marketing Category
C73584
G
Generic Name
buprenorphine hydrochloride and naloxone hydrochloride
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateOctober 1, 2023
FDA Product Classification

INGREDIENTS (11)

BUPRENORPHINE HYDROCHLORIDEActive
Quantity: 8 mg in 1 1
Code: 56W8MW3EN1
Classification: ACTIM
NALOXONE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: F850569PQR
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT

buprenorphine hydrochloride and naloxone hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50383-294
Application NumberANDA204431
Product Classification
M
Marketing Category
C73584
G
Generic Name
buprenorphine hydrochloride and naloxone hydrochloride
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateOctober 1, 2023
FDA Product Classification

INGREDIENTS (11)

BUPRENORPHINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: 56W8MW3EN1
Classification: ACTIM
NALOXONE HYDROCHLORIDEActive
Quantity: 0.5 mg in 1 1
Code: F850569PQR
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT

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Buprenorphine and Naloxone - FDA Drug Approval Details