Buprenorphine and Naloxone

These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM. BUPRENORPHINE and NALOXONE sublingual film, for sublingual or buccal use, CIII.Initial U.S. Approval: 2002

Approved

Approval ID

4210afeb-474c-d842-d68e-af7e0021851a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 31, 2024

Manufacturers

FDA

Alvogen Inc.

DUNS: 008057330

Products 4

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 Code47781-356

Application NumberANDA205954

Product Classification

Marketing Category

C73584

Generic Name

Buprenorphine and Naloxone

Product Specifications

Route of AdministrationSUBLINGUAL, BUCCAL

Effective DateMarch 30, 2018

FDA Product Classification

INGREDIENTS (17)

POLYETHYLENE OXIDE 100000Inactive

Code: V46Y6OJ5QB

Classification: IACT

MALTITOLInactive

Code: D65DG142WK

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95K

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

POLYETHYLENE OXIDE 900000Inactive

Code: 16P9295IIL

Classification: IACT

BUPRENORPHINE HYDROCHLORIDEActive

Quantity: 4 mg in 1 1

Code: 56W8MW3EN1

Classification: ACTIM

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QP

Classification: IACT

ACESULFAME POTASSIUMInactive

Code: 23OV73Q5G9

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

POLYETHYLENE OXIDE 200000Inactive

Code: 11628IH70O

Classification: IACT

NALOXONE HYDROCHLORIDE DIHYDRATEActive

Quantity: 1 mg in 1 1

Code: 5Q187997EE

Classification: ACTIM

Buprenorphine and Naloxone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code47781-355

Application NumberANDA205954

Product Classification

Marketing Category

C73584

Generic Name

Buprenorphine and Naloxone

Product Specifications

Route of AdministrationSUBLINGUAL, BUCCAL

Effective DateMarch 30, 2018

FDA Product Classification

INGREDIENTS (17)

BUPRENORPHINE HYDROCHLORIDEActive

Quantity: 2 mg in 1 1

Code: 56W8MW3EN1

Classification: ACTIM

POLYETHYLENE OXIDE 100000Inactive

Code: V46Y6OJ5QB

Classification: IACT

MALTITOLInactive

Code: D65DG142WK

Classification: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QP

Classification: IACT

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95K

Classification: IACT

ACESULFAME POTASSIUMInactive

Code: 23OV73Q5G9

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

POLYETHYLENE OXIDE 200000Inactive

Code: 11628IH70O

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE OXIDE 900000Inactive

Code: 16P9295IIL

Classification: IACT

NALOXONE HYDROCHLORIDE DIHYDRATEActive

Quantity: 0.5 mg in 1 1

Code: 5Q187997EE

Classification: ACTIM

Buprenorphine and Naloxone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code47781-358

Application NumberANDA205954

Product Classification

Marketing Category

C73584

Generic Name

Buprenorphine and Naloxone

Product Specifications

Route of AdministrationSUBLINGUAL, BUCCAL

Effective DateMarch 30, 2018

FDA Product Classification

INGREDIENTS (17)

BUPRENORPHINE HYDROCHLORIDEActive

Quantity: 12 mg in 1 1

Code: 56W8MW3EN1

Classification: ACTIM

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QP

Classification: IACT

POLYETHYLENE OXIDE 100000Inactive

Code: V46Y6OJ5QB

Classification: IACT

MALTITOLInactive

Code: D65DG142WK

Classification: IACT

ACESULFAME POTASSIUMInactive

Code: 23OV73Q5G9

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95K

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE OXIDE 200000Inactive

Code: 11628IH70O

Classification: IACT

POLYETHYLENE OXIDE 900000Inactive

Code: 16P9295IIL

Classification: IACT

NALOXONE HYDROCHLORIDE DIHYDRATEActive

Quantity: 3 mg in 1 1

Code: 5Q187997EE

Classification: ACTIM

Buprenorphine and Naloxone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code47781-357

Application NumberANDA205954

Product Classification

Marketing Category

C73584

Generic Name

Buprenorphine and Naloxone

Product Specifications

Route of AdministrationSUBLINGUAL, BUCCAL

Effective DateMarch 30, 2018

FDA Product Classification

INGREDIENTS (17)

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

BUPRENORPHINE HYDROCHLORIDEActive

Quantity: 8 mg in 1 1

Code: 56W8MW3EN1

Classification: ACTIM

POLYETHYLENE OXIDE 100000Inactive

Code: V46Y6OJ5QB

Classification: IACT

MALTITOLInactive

Code: D65DG142WK

Classification: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QP

Classification: IACT

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95K

Classification: IACT

ACESULFAME POTASSIUMInactive

Code: 23OV73Q5G9

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

POLYETHYLENE OXIDE 200000Inactive

Code: 11628IH70O

Classification: IACT

POLYETHYLENE OXIDE 900000Inactive

Code: 16P9295IIL

Classification: IACT

NALOXONE HYDROCHLORIDE DIHYDRATEActive

Quantity: 2 mg in 1 1

Code: 5Q187997EE

Classification: ACTIM

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Buprenorphine and Naloxone

Products 4

Buprenorphine and Naloxone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

Buprenorphine and Naloxone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

Buprenorphine and Naloxone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

Buprenorphine and Naloxone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

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