NDC Code 63481-952-60 - Buprenorphine Hydrochloride

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUPRENORPHINE HYDROCHLORIDE(UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)	BUPRENORPHINE	75 ug

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63481-161-60	60 in 1 CARTON	06/01/2015
1		1 in 1 POUCH Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUPRENORPHINE HYDROCHLORIDE(UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)	BUPRENORPHINE	150 ug

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63481-207-60	60 in 1 CARTON	06/01/2015
1		1 in 1 POUCH Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUPRENORPHINE HYDROCHLORIDE(UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)	BUPRENORPHINE	300 ug

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63481-348-60	60 in 1 CARTON	06/01/2015
1		1 in 1 POUCH Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUPRENORPHINE HYDROCHLORIDE(UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)	BUPRENORPHINE	450 ug

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63481-519-60	60 in 1 CARTON	06/01/2015
1		1 in 1 POUCH Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUPRENORPHINE HYDROCHLORIDE(UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)	BUPRENORPHINE	600 ug

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63481-685-60	60 in 1 CARTON	06/01/2015
1		1 in 1 POUCH Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUPRENORPHINE HYDROCHLORIDE(UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)	BUPRENORPHINE	750 ug

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63481-820-60	60 in 1 CARTON	06/01/2015
1		1 in 1 POUCH Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUPRENORPHINE HYDROCHLORIDE(UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)	BUPRENORPHINE	900 ug

Ingredient Name	Strength
Inactive Ingredients
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)