NDC Code(s) : 59385-021-01, 59385-021-60, 59385-022-01, 59385-022-60, 59385-023-01, 59385-023-60, 59385-024-01, 59385-024-60, 59385-025-01, 59385-025-60, 59385-026-01, 59385-026-60, 59385-027-01, 59385-027-60
Packager : BioDelivery Sciences International Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BELBUCAbuprenorphine hydrochloride FILM, SOLUBLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59385-021
Route of Administration BUCCAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
buprenorphine hydrochloride(UNII: 56W8MW3EN1)
(buprenorphine - UNII:40D3SCR4GZ) 		buprenorphine75 ug
Inactive Ingredients
Ingredient Name Strength
HYDROXYETHYL CELLULOSE (280 MPA.S AT 5%)(UNII: B24JYI97VR)
Titanium Dioxide(UNII: 15FIX9V2JP)
Peppermint Oil(UNII: AV092KU4JH)
Propylene Glycol(UNII: 6DC9Q167V3)
Sodium Benzoate(UNII: OJ245FE5EU)
Methylparaben(UNII: A2I8C7HI9T)
Propylparaben(UNII: Z8IX2SC1OH)
Ferric Oxide Yellow(UNII: EX438O2MRT)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(UNII: KH7I04HPUU)
Sodium Hydroxide(UNII: 55X04QC32I)
Polycarbophil(UNII: W25LM17A4W)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UNII: UKE75GEA7F)
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 38 MPA.S AT 2%)(UNII: YGX74DKE74)
Saccharin Sodium(UNII: SB8ZUX40TY)
Product Characteristics
Color YELLOW Score no score
Shape RECTANGLE Size 12 mm
Flavor PEPPERMINT Imprint Code E0
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59385-021-6060 in 1 CARTON 09/01/2017
1NDC:59385-021-011 in 1 POUCH Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207932 09/01/2017
BELBUCAbuprenorphine hydrochloride FILM, SOLUBLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59385-022
Route of Administration BUCCAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
buprenorphine hydrochloride(UNII: 56W8MW3EN1)
(buprenorphine - UNII:40D3SCR4GZ) 		buprenorphine150 ug
Inactive Ingredients
Ingredient Name Strength
HYDROXYETHYL CELLULOSE (280 MPA.S AT 5%)(UNII: B24JYI97VR)
Titanium Dioxide(UNII: 15FIX9V2JP)
Peppermint Oil(UNII: AV092KU4JH)
Propylene Glycol(UNII: 6DC9Q167V3)
Sodium Benzoate(UNII: OJ245FE5EU)
Methylparaben(UNII: A2I8C7HI9T)
Propylparaben(UNII: Z8IX2SC1OH)
Ferric Oxide Yellow(UNII: EX438O2MRT)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(UNII: KH7I04HPUU)
Sodium Hydroxide(UNII: 55X04QC32I)
Polycarbophil(UNII: W25LM17A4W)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UNII: UKE75GEA7F)
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 38 MPA.S AT 2%)(UNII: YGX74DKE74)
Saccharin Sodium(UNII: SB8ZUX40TY)
Product Characteristics
Color YELLOW Score no score
Shape RECTANGLE Size 24 mm
Flavor PEPPERMINT Imprint Code E1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59385-022-6060 in 1 CARTON 10/01/2017
1NDC:59385-022-011 in 1 POUCH Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207932 10/01/2017
BELBUCAbuprenorphine hydrochloride FILM, SOLUBLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59385-023
Route of Administration BUCCAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
buprenorphine hydrochloride(UNII: 56W8MW3EN1)
(buprenorphine - UNII:40D3SCR4GZ) 		buprenorphine300 ug
Inactive Ingredients
Ingredient Name Strength
HYDROXYETHYL CELLULOSE (280 MPA.S AT 5%)(UNII: B24JYI97VR)
Titanium Dioxide(UNII: 15FIX9V2JP)
Peppermint Oil(UNII: AV092KU4JH)
Propylene Glycol(UNII: 6DC9Q167V3)
Sodium Benzoate(UNII: OJ245FE5EU)
Methylparaben(UNII: A2I8C7HI9T)
Propylparaben(UNII: Z8IX2SC1OH)
Ferric Oxide Yellow(UNII: EX438O2MRT)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(UNII: KH7I04HPUU)
Sodium Hydroxide(UNII: 55X04QC32I)
Polycarbophil(UNII: W25LM17A4W)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UNII: UKE75GEA7F)
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 38 MPA.S AT 2%)(UNII: YGX74DKE74)
Saccharin Sodium(UNII: SB8ZUX40TY)
Product Characteristics
Color YELLOW Score no score
Shape RECTANGLE Size 9 mm
Flavor PEPPERMINT Imprint Code E3
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59385-023-6060 in 1 CARTON 09/01/2017
1NDC:59385-023-011 in 1 POUCH Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207932 09/01/2017
BELBUCAbuprenorphine hydrochloride FILM, SOLUBLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59385-024
Route of Administration BUCCAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
buprenorphine hydrochloride(UNII: 56W8MW3EN1)
(buprenorphine - UNII:40D3SCR4GZ) 		buprenorphine450 ug
Inactive Ingredients
Ingredient Name Strength
HYDROXYETHYL CELLULOSE (280 MPA.S AT 5%)(UNII: B24JYI97VR)
Titanium Dioxide(UNII: 15FIX9V2JP)
Peppermint Oil(UNII: AV092KU4JH)
Propylene Glycol(UNII: 6DC9Q167V3)
Sodium Benzoate(UNII: OJ245FE5EU)
Methylparaben(UNII: A2I8C7HI9T)
Propylparaben(UNII: Z8IX2SC1OH)
Ferric Oxide Yellow(UNII: EX438O2MRT)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(UNII: KH7I04HPUU)
Sodium Hydroxide(UNII: 55X04QC32I)
Polycarbophil(UNII: W25LM17A4W)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UNII: UKE75GEA7F)
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 38 MPA.S AT 2%)(UNII: YGX74DKE74)
Saccharin Sodium(UNII: SB8ZUX40TY)
Product Characteristics
Color YELLOW Score no score
Shape RECTANGLE Size 14 mm
Flavor PEPPERMINT Imprint Code E4
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59385-024-6060 in 1 CARTON 21/08/2017
1NDC:59385-024-011 in 1 POUCH Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207932 08/21/2017
BELBUCAbuprenorphine hydrochloride FILM, SOLUBLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59385-025
Route of Administration BUCCAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
buprenorphine hydrochloride(UNII: 56W8MW3EN1)
(buprenorphine - UNII:40D3SCR4GZ) 		buprenorphine600 ug
Inactive Ingredients
Ingredient Name Strength
HYDROXYETHYL CELLULOSE (280 MPA.S AT 5%)(UNII: B24JYI97VR)
Titanium Dioxide(UNII: 15FIX9V2JP)
Peppermint Oil(UNII: AV092KU4JH)
Propylene Glycol(UNII: 6DC9Q167V3)
Sodium Benzoate(UNII: OJ245FE5EU)
Methylparaben(UNII: A2I8C7HI9T)
Propylparaben(UNII: Z8IX2SC1OH)
Ferric Oxide Yellow(UNII: EX438O2MRT)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(UNII: KH7I04HPUU)
Sodium Hydroxide(UNII: 55X04QC32I)
Polycarbophil(UNII: W25LM17A4W)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UNII: UKE75GEA7F)
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 38 MPA.S AT 2%)(UNII: YGX74DKE74)
Saccharin Sodium(UNII: SB8ZUX40TY)
Product Characteristics
Color YELLOW Score no score
Shape RECTANGLE Size 19 mm
Flavor PEPPERMINT Imprint Code E6
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59385-025-6060 in 1 CARTON 24/08/2017
1NDC:59385-025-011 in 1 POUCH Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207932 08/24/2017
BELBUCAbuprenorphine hydrochloride FILM, SOLUBLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59385-026
Route of Administration BUCCAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
buprenorphine hydrochloride(UNII: 56W8MW3EN1)
(buprenorphine - UNII:40D3SCR4GZ) 		buprenorphine750 ug
Inactive Ingredients
Ingredient Name Strength
HYDROXYETHYL CELLULOSE (280 MPA.S AT 5%)(UNII: B24JYI97VR)
Titanium Dioxide(UNII: 15FIX9V2JP)
Peppermint Oil(UNII: AV092KU4JH)
Propylene Glycol(UNII: 6DC9Q167V3)
Sodium Benzoate(UNII: OJ245FE5EU)
Methylparaben(UNII: A2I8C7HI9T)
Propylparaben(UNII: Z8IX2SC1OH)
Ferric Oxide Yellow(UNII: EX438O2MRT)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(UNII: KH7I04HPUU)
Sodium Hydroxide(UNII: 55X04QC32I)
Polycarbophil(UNII: W25LM17A4W)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UNII: UKE75GEA7F)
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 38 MPA.S AT 2%)(UNII: YGX74DKE74)
Saccharin Sodium(UNII: SB8ZUX40TY)
Product Characteristics
Color YELLOW Score no score
Shape RECTANGLE Size 23 mm
Flavor PEPPERMINT Imprint Code E7
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59385-026-6060 in 1 CARTON 10/01/2017
1NDC:59385-026-011 in 1 POUCH Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207932 10/01/2017
BELBUCAbuprenorphine hydrochloride FILM, SOLUBLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59385-027
Route of Administration BUCCAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
buprenorphine hydrochloride(UNII: 56W8MW3EN1)
(buprenorphine - UNII:40D3SCR4GZ) 		buprenorphine900 ug
Inactive Ingredients
Ingredient Name Strength
HYDROXYETHYL CELLULOSE (280 MPA.S AT 5%)(UNII: B24JYI97VR)
Titanium Dioxide(UNII: 15FIX9V2JP)
Peppermint Oil(UNII: AV092KU4JH)
Propylene Glycol(UNII: 6DC9Q167V3)
Sodium Benzoate(UNII: OJ245FE5EU)
Methylparaben(UNII: A2I8C7HI9T)
Propylparaben(UNII: Z8IX2SC1OH)
Ferric Oxide Yellow(UNII: EX438O2MRT)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(UNII: KH7I04HPUU)
Sodium Hydroxide(UNII: 55X04QC32I)
Polycarbophil(UNII: W25LM17A4W)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UNII: UKE75GEA7F)
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 38 MPA.S AT 2%)(UNII: YGX74DKE74)
Saccharin Sodium(UNII: SB8ZUX40TY)
Product Characteristics
Color YELLOW Score no score
Shape RECTANGLE Size 28 mm
Flavor PEPPERMINT Imprint Code E9
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59385-027-6060 in 1 CARTON 08/11/2017
1NDC:59385-027-011 in 1 POUCH Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207932 08/11/2017

LABELER - BioDelivery Sciences International Inc(016058955)

PRINCIPAL DISPLAY PANEL

NDC 59385-021-60

CIII

Belbuca ®
(buprenorphine buccal film)

Push To
Open

75 mcg

60 pouches containing 1 buccal film each

Use entire film. Do not cut, tear, chew or swallow film.

Keep Belbuca out of sight and reach of children.
Children who accidentally take Belbuca will
need emergency medical care.

Dispense the enclosed
Medication Guide
to each patient.

Rx only

Principal Display Panel - 75 mcg Film Pouch Box

PRINCIPAL DISPLAY PANEL

NDC 59385-022-60

CIII

Belbuca ®
(buprenorphine buccal film)

Push To
Open

150 mcg

60 pouches containing 1 buccal film each

Use entire film. Do not cut, tear, chew or swallow film.

Keep Belbuca out of sight and reach of children.
Children who accidentally take Belbuca will
need emergency medical care.

Dispense the enclosed
Medication Guide
to each patient.

Rx only

Principal Display Panel - 150 mcg Film Pouch Box

PRINCIPAL DISPLAY PANEL

NDC 59385-023-60

CIII

Belbuca ®
(buprenorphine buccal film)

Push To
Open

300 mcg

60 pouches containing 1 buccal film each

Use entire film. Do not cut, tear, chew or swallow film.

Keep Belbuca out of sight and reach of children.
Children who accidentally take Belbuca will
need emergency medical care.

Dispense the enclosed
Medication Guide
to each patient.

Rx only

Principal Display Panel - 300 mcg Film Pouch Box

PRINCIPAL DISPLAY PANEL

NDC 59385-024-60

CIII

Belbuca ®
(buprenorphine buccal film)

Push To
Open

450 mcg

60 pouches containing 1 buccal film each

Use entire film. Do not cut, tear, chew or swallow film.

Keep Belbuca out of sight and reach of children.
Children who accidentally take Belbuca will
need emergency medical care.

Dispense the enclosed
Medication Guide
to each patient.

Rx only

Principal Display Panel - 450 mcg Film Pouch Box

PRINCIPAL DISPLAY PANEL

NDC 59385-025-60

CIII

Belbuca ®
(buprenorphine buccal film)

Push To
Open

600 mcg

60 pouches containing 1 buccal film each

Use entire film. Do not cut, tear, chew or swallow film.

Keep Belbuca out of sight and reach of children.
Children who accidentally take Belbuca will
need emergency medical care.

Dispense the enclosed
Medication Guide
to each patient.

Rx only

Principal Display Panel - 600 mcg Film Pouch Box

PRINCIPAL DISPLAY PANEL

NDC 59385-026-60

CIII

Belbuca ®
(buprenorphine buccal film)

Push To
Open

750 mcg

60 pouches containing 1 buccal film each

Use entire film. Do not cut, tear, chew or swallow film.

Keep Belbuca out of sight and reach of children.
Children who accidentally take Belbuca will
need emergency medical care.

Dispense the enclosed
Medication Guide
to each patient.

Rx only

Principal Display Panel - 750 mcg Film Pouch Box

PRINCIPAL DISPLAY PANEL

NDC 59385-027-60

CIII

Belbuca ®
(buprenorphine buccal film)

Push To
Open

900 mcg

60 pouches containing 1 buccal film each

Use entire film. Do not cut, tear, chew or swallow film.

Keep Belbuca out of sight and reach of children.
Children who accidentally take Belbuca will
need emergency medical care.

Dispense the enclosed
Medication Guide
to each patient.

Rx only

Principal Display Panel - 900 mcg Film Pouch Box