BELBUCA

These highlights do not include all the information needed to use BELBUCA safely and effectively. See full prescribing information for BELBUCA. BELBUCA (buprenorphine buccal film), CIII Initial U.S. Approval: 1981

Approved

Approval ID

bc2b7a3d-72cf-497c-95b0-ba2b71f63c64

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 21, 2023

Manufacturers

FDA

BioDelivery Sciences International Inc

DUNS: 016058955

Products 7

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

buprenorphine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59385-022

Application NumberNDA207932

Product Classification

Marketing Category

C73594

Generic Name

buprenorphine hydrochloride

Product Specifications

Route of AdministrationBUCCAL

Effective DateDecember 21, 2023

FDA Product Classification

INGREDIENTS (17)

buprenorphine hydrochlorideActive

Quantity: 150 ug in 1 1

Code: 56W8MW3EN1

Classification: ACTIM

HYDROXYETHYL CELLULOSE (280 MPA.S AT 5%)Inactive

Code: B24JYI97VR

Classification: IACT

Titanium DioxideInactive

Code: 15FIX9V2JP

Classification: IACT

Peppermint OilInactive

Code: AV092KU4JH

Classification: IACT

PropylparabenInactive

Code: Z8IX2SC1OH

Classification: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3

Classification: IACT

Sodium BenzoateInactive

Code: OJ245FE5EU

Classification: IACT

MethylparabenInactive

Code: A2I8C7HI9T

Classification: IACT

Ferric Oxide YellowInactive

Code: EX438O2MRT

Classification: IACT

.ALPHA.-TOCOPHEROL ACETATEInactive

Code: 9E8X80D2L0

Classification: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSInactive

Code: KH7I04HPUU

Classification: IACT

Sodium HydroxideInactive

Code: 55X04QC32I

Classification: IACT

PolycarbophilInactive

Code: W25LM17A4W

Classification: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7F

Classification: IACT

CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 38 MPA.S AT 2%)Inactive

Code: YGX74DKE74

Classification: IACT

Saccharin SodiumInactive

Code: SB8ZUX40TY

Classification: IACT

buprenorphine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59385-023

Application NumberNDA207932

Product Classification

Marketing Category

C73594

Generic Name

buprenorphine hydrochloride

Product Specifications

Route of AdministrationBUCCAL

Effective DateDecember 21, 2023

FDA Product Classification

INGREDIENTS (17)

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

MethylparabenInactive

Code: A2I8C7HI9T

Classification: IACT

buprenorphine hydrochlorideActive

Quantity: 300 ug in 1 1

Code: 56W8MW3EN1

Classification: ACTIM

HYDROXYETHYL CELLULOSE (280 MPA.S AT 5%)Inactive

Code: B24JYI97VR

Classification: IACT

Titanium DioxideInactive

Code: 15FIX9V2JP

Classification: IACT

Peppermint OilInactive

Code: AV092KU4JH

Classification: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3

Classification: IACT

Sodium BenzoateInactive

Code: OJ245FE5EU

Classification: IACT

PropylparabenInactive

Code: Z8IX2SC1OH

Classification: IACT

Ferric Oxide YellowInactive

Code: EX438O2MRT

Classification: IACT

.ALPHA.-TOCOPHEROL ACETATEInactive

Code: 9E8X80D2L0

Classification: IACT

SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSInactive

Code: KH7I04HPUU

Classification: IACT

Sodium HydroxideInactive

Code: 55X04QC32I

Classification: IACT

PolycarbophilInactive

Code: W25LM17A4W

Classification: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7F

Classification: IACT

CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 38 MPA.S AT 2%)Inactive

Code: YGX74DKE74

Classification: IACT

Saccharin SodiumInactive

Code: SB8ZUX40TY

Classification: IACT

buprenorphine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59385-021

Application NumberNDA207932

Product Classification

Marketing Category

C73594

Generic Name

buprenorphine hydrochloride

Product Specifications

Route of AdministrationBUCCAL

Effective DateDecember 21, 2023

FDA Product Classification

INGREDIENTS (17)

buprenorphine hydrochlorideActive

Quantity: 75 ug in 1 1

Code: 56W8MW3EN1

Classification: ACTIM

HYDROXYETHYL CELLULOSE (280 MPA.S AT 5%)Inactive

Code: B24JYI97VR

Classification: IACT

Titanium DioxideInactive

Code: 15FIX9V2JP

Classification: IACT

Peppermint OilInactive

Code: AV092KU4JH

Classification: IACT

Sodium BenzoateInactive

Code: OJ245FE5EU

Classification: IACT

.ALPHA.-TOCOPHEROL ACETATEInactive

Code: 9E8X80D2L0

Classification: IACT

SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSInactive

Code: KH7I04HPUU

Classification: IACT

MethylparabenInactive

Code: A2I8C7HI9T

Classification: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3

Classification: IACT

PropylparabenInactive

Code: Z8IX2SC1OH

Classification: IACT

Ferric Oxide YellowInactive

Code: EX438O2MRT

Classification: IACT

Sodium HydroxideInactive

Code: 55X04QC32I

Classification: IACT

PolycarbophilInactive

Code: W25LM17A4W

Classification: IACT

CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 38 MPA.S AT 2%)Inactive

Code: YGX74DKE74

Classification: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7F

Classification: IACT

Saccharin SodiumInactive

Code: SB8ZUX40TY

Classification: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

buprenorphine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59385-027

Application NumberNDA207932

Product Classification

Marketing Category

C73594

Generic Name

buprenorphine hydrochloride

Product Specifications

Route of AdministrationBUCCAL

Effective DateDecember 21, 2023

FDA Product Classification

INGREDIENTS (17)

Peppermint OilInactive

Code: AV092KU4JH

Classification: IACT

Sodium HydroxideInactive

Code: 55X04QC32I

Classification: IACT

PropylparabenInactive

Code: Z8IX2SC1OH

Classification: IACT

HYDROXYETHYL CELLULOSE (280 MPA.S AT 5%)Inactive

Code: B24JYI97VR

Classification: IACT

Titanium DioxideInactive

Code: 15FIX9V2JP

Classification: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3

Classification: IACT

Sodium BenzoateInactive

Code: OJ245FE5EU

Classification: IACT

MethylparabenInactive

Code: A2I8C7HI9T

Classification: IACT

Ferric Oxide YellowInactive

Code: EX438O2MRT

Classification: IACT

buprenorphine hydrochlorideActive

Quantity: 900 ug in 1 1

Code: 56W8MW3EN1

Classification: ACTIM

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

.ALPHA.-TOCOPHEROL ACETATEInactive

Code: 9E8X80D2L0

Classification: IACT

SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSInactive

Code: KH7I04HPUU

Classification: IACT

PolycarbophilInactive

Code: W25LM17A4W

Classification: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7F

Classification: IACT

CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 38 MPA.S AT 2%)Inactive

Code: YGX74DKE74

Classification: IACT

Saccharin SodiumInactive

Code: SB8ZUX40TY

Classification: IACT

buprenorphine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59385-025

Application NumberNDA207932

Product Classification

Marketing Category

C73594

Generic Name

buprenorphine hydrochloride

Product Specifications

Route of AdministrationBUCCAL

Effective DateDecember 21, 2023

FDA Product Classification

INGREDIENTS (17)

HYDROXYETHYL CELLULOSE (280 MPA.S AT 5%)Inactive

Code: B24JYI97VR

Classification: IACT

Titanium DioxideInactive

Code: 15FIX9V2JP

Classification: IACT

buprenorphine hydrochlorideActive

Quantity: 600 ug in 1 1

Code: 56W8MW3EN1

Classification: ACTIM

Peppermint OilInactive

Code: AV092KU4JH

Classification: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3

Classification: IACT

PropylparabenInactive

Code: Z8IX2SC1OH

Classification: IACT

Ferric Oxide YellowInactive

Code: EX438O2MRT

Classification: IACT

Sodium BenzoateInactive

Code: OJ245FE5EU

Classification: IACT

MethylparabenInactive

Code: A2I8C7HI9T

Classification: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

.ALPHA.-TOCOPHEROL ACETATEInactive

Code: 9E8X80D2L0

Classification: IACT

SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSInactive

Code: KH7I04HPUU

Classification: IACT

Sodium HydroxideInactive

Code: 55X04QC32I

Classification: IACT

PolycarbophilInactive

Code: W25LM17A4W

Classification: IACT

CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 38 MPA.S AT 2%)Inactive

Code: YGX74DKE74

Classification: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7F

Classification: IACT

Saccharin SodiumInactive

Code: SB8ZUX40TY

Classification: IACT

buprenorphine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59385-024

Application NumberNDA207932

Product Classification

Marketing Category

C73594

Generic Name

buprenorphine hydrochloride

Product Specifications

Route of AdministrationBUCCAL

Effective DateDecember 21, 2023

FDA Product Classification

INGREDIENTS (17)

buprenorphine hydrochlorideActive

Quantity: 450 ug in 1 1

Code: 56W8MW3EN1

Classification: ACTIM

Titanium DioxideInactive

Code: 15FIX9V2JP

Classification: IACT

HYDROXYETHYL CELLULOSE (280 MPA.S AT 5%)Inactive

Code: B24JYI97VR

Classification: IACT

Peppermint OilInactive

Code: AV092KU4JH

Classification: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3

Classification: IACT

MethylparabenInactive

Code: A2I8C7HI9T

Classification: IACT

Sodium BenzoateInactive

Code: OJ245FE5EU

Classification: IACT

Ferric Oxide YellowInactive

Code: EX438O2MRT

Classification: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

PropylparabenInactive

Code: Z8IX2SC1OH

Classification: IACT

.ALPHA.-TOCOPHEROL ACETATEInactive

Code: 9E8X80D2L0

Classification: IACT

SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSInactive

Code: KH7I04HPUU

Classification: IACT

Sodium HydroxideInactive

Code: 55X04QC32I

Classification: IACT

PolycarbophilInactive

Code: W25LM17A4W

Classification: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7F

Classification: IACT

CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 38 MPA.S AT 2%)Inactive

Code: YGX74DKE74

Classification: IACT

Saccharin SodiumInactive

Code: SB8ZUX40TY

Classification: IACT

buprenorphine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code59385-026

Application NumberNDA207932

Product Classification

Marketing Category

C73594

Generic Name

buprenorphine hydrochloride

Product Specifications

Route of AdministrationBUCCAL

Effective DateDecember 21, 2023

FDA Product Classification

INGREDIENTS (17)

buprenorphine hydrochlorideActive

Quantity: 750 ug in 1 1

Code: 56W8MW3EN1

Classification: ACTIM

HYDROXYETHYL CELLULOSE (280 MPA.S AT 5%)Inactive

Code: B24JYI97VR

Classification: IACT

Titanium DioxideInactive

Code: 15FIX9V2JP

Classification: IACT

Sodium BenzoateInactive

Code: OJ245FE5EU

Classification: IACT

MethylparabenInactive

Code: A2I8C7HI9T

Classification: IACT

PropylparabenInactive

Code: Z8IX2SC1OH

Classification: IACT

Ferric Oxide YellowInactive

Code: EX438O2MRT

Classification: IACT

Peppermint OilInactive

Code: AV092KU4JH

Classification: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3

Classification: IACT

.ALPHA.-TOCOPHEROL ACETATEInactive

Code: 9E8X80D2L0

Classification: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSL

Classification: IACT

SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSInactive

Code: KH7I04HPUU

Classification: IACT

Sodium HydroxideInactive

Code: 55X04QC32I

Classification: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7F

Classification: IACT

PolycarbophilInactive

Code: W25LM17A4W

Classification: IACT

CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 38 MPA.S AT 2%)Inactive

Code: YGX74DKE74

Classification: IACT

Saccharin SodiumInactive

Code: SB8ZUX40TY

Classification: IACT

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BELBUCA

Products 7

buprenorphine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

buprenorphine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

buprenorphine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

buprenorphine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

buprenorphine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

buprenorphine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

buprenorphine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

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