NDC Code(s) : 63481-161-60, 63481-207-60, 63481-348-60, 63481-519-60, 63481-685-60, 63481-820-60, 63481-952-60
Packager : Endo Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Belbucabuprenorphine hydrochloride FILM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63481-161
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
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)(UNII: 8136Y38GY5)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
METHYLPARABEN(UNII: A2I8C7HI9T)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(UNII: KH7I04HPUU)
PEPPERMINT OIL(UNII: AV092KU4JH)
POLYCARBOPHIL(UNII: W25LM17A4W)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color YELLOW, WHITE Score
Shape Size
Flavor Imprint Code E0
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63481-161-6060 in 1 CARTON 06/01/2015
11 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 06/01/2015 10/31/2018
Belbucabuprenorphine hydrochloride FILM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63481-207
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
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)(UNII: 8136Y38GY5)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
METHYLPARABEN(UNII: A2I8C7HI9T)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(UNII: KH7I04HPUU)
PEPPERMINT OIL(UNII: AV092KU4JH)
POLYCARBOPHIL(UNII: W25LM17A4W)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color YELLOW, WHITE Score
Shape Size
Flavor Imprint Code E1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63481-207-6060 in 1 CARTON 06/01/2015
11 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 06/01/2015 10/31/2018
Belbucabuprenorphine hydrochloride FILM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63481-348
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
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)(UNII: 8136Y38GY5)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
METHYLPARABEN(UNII: A2I8C7HI9T)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(UNII: KH7I04HPUU)
PEPPERMINT OIL(UNII: AV092KU4JH)
POLYCARBOPHIL(UNII: W25LM17A4W)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color YELLOW, WHITE Score
Shape Size
Flavor Imprint Code E3
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63481-348-6060 in 1 CARTON 06/01/2015
11 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 06/01/2015 10/31/2018
Belbucabuprenorphine hydrochloride FILM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63481-519
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
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)(UNII: 8136Y38GY5)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
METHYLPARABEN(UNII: A2I8C7HI9T)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(UNII: KH7I04HPUU)
PEPPERMINT OIL(UNII: AV092KU4JH)
POLYCARBOPHIL(UNII: W25LM17A4W)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color YELLOW, WHITE Score
Shape Size
Flavor Imprint Code E4
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63481-519-6060 in 1 CARTON 06/01/2015
11 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 06/01/2015 10/31/2018
Belbucabuprenorphine hydrochloride FILM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63481-685
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
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)(UNII: 8136Y38GY5)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
METHYLPARABEN(UNII: A2I8C7HI9T)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(UNII: KH7I04HPUU)
PEPPERMINT OIL(UNII: AV092KU4JH)
POLYCARBOPHIL(UNII: W25LM17A4W)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color YELLOW, WHITE Score
Shape Size
Flavor Imprint Code E6
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63481-685-6060 in 1 CARTON 06/01/2015
11 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 06/01/2015 10/31/2018
Belbucabuprenorphine hydrochloride FILM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63481-820
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
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)(UNII: 8136Y38GY5)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
METHYLPARABEN(UNII: A2I8C7HI9T)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(UNII: KH7I04HPUU)
PEPPERMINT OIL(UNII: AV092KU4JH)
POLYCARBOPHIL(UNII: W25LM17A4W)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color YELLOW, WHITE Score
Shape Size
Flavor Imprint Code E7
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63481-820-6060 in 1 CARTON 06/01/2015
11 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 06/01/2015 10/31/2018
Belbucabuprenorphine hydrochloride FILM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63481-952
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
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)(UNII: 8136Y38GY5)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
METHYLPARABEN(UNII: A2I8C7HI9T)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(UNII: KH7I04HPUU)
PEPPERMINT OIL(UNII: AV092KU4JH)
POLYCARBOPHIL(UNII: W25LM17A4W)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color YELLOW, WHITE Score
Shape Size
Flavor Imprint Code E9
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63481-952-6060 in 1 CARTON 06/01/2015
11 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 06/01/2015 10/31/2018

PRINCIPAL DISPLAY PANEL

Package Label – Principle Display Panel – 75ug Pouch Label

75ug Pouch Label

PRINCIPAL DISPLAY PANEL

Package Label – Principle Display Panel – 75ug Carton Label

75ug Carton Label

PRINCIPAL DISPLAY PANEL

Package Label – Principle Display Panel – 150ug Pouch Label

150ug Pouch Label

PRINCIPAL DISPLAY PANEL

Package Label – Principle Display Panel – 150ug Carton Label 

150ug Carton Label

PRINCIPAL DISPLAY PANEL

Package Label – Principle Display Panel – 300ug Pouch Label

300ug Pouch Label

PRINCIPAL DISPLAY PANEL

Package Label – Principle Display Panel – 300ug Carton Label

300ug Carton Label

PRINCIPAL DISPLAY PANEL

Package Label – Principle Display Panel – 450ug Pouch Label

450ug Pouch Label

PRINCIPAL DISPLAY PANEL

Package Label – Principle Display Panel – 450ug Carton Label

450ug Carton Label

PRINCIPAL DISPLAY PANEL

Package Label – Principle Display Panel – 600ug Pouch Label

600ug Pouch Label

PRINCIPAL DISPLAY PANEL

Package Label – Principle Display Panel – 600ug Carton Label 

600ug Carton Label

PRINCIPAL DISPLAY PANEL

Package Label – Principle Display Panel – 750ug Pouch Label

750ug Pouch Label

PRINCIPAL DISPLAY PANEL

Package Label – Principle Display Panel – 750ug Carton Label

750ug Carton Label

PRINCIPAL DISPLAY PANEL

Package Label – Principle Display Panel – 900ug Pouch Label

900ug Pouch Label

PRINCIPAL DISPLAY PANEL

Package Label – Principle Display Panel – 900ug Carton Label

900ug Carton Label