NDC Code 47781-355-03 - Buprenorphine Hydrochloride

NDC Code(s) : 47781-355-11, 47781-355-03, 47781-356-11, 47781-356-03, 47781-357-11, 47781-357-03, 47781-358-11, 47781-358-03
Packager : Alvogen Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Buprenorphine and Naloxone Buprenorphine and Naloxone FILM

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:47781-355
Route of Administration	SUBLINGUAL, BUCCAL	DEA Schedule	CIII

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUPRENORPHINE HYDROCHLORIDE(UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)	BUPRENORPHINE	2 mg
NALOXONE HYDROCHLORIDE DIHYDRATE(UNII: 5Q187997EE) (NALOXONE - UNII:36B82AMQ7N)	NALOXONE	0.5 mg

Ingredient Name	Strength
Inactive Ingredients
POLYETHYLENE OXIDE 100000(UNII: V46Y6OJ5QB)
MALTITOL(UNII: D65DG142WK)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
ACESULFAME POTASSIUM(UNII: 23OV73Q5G9)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
ALCOHOL(UNII: 3K9958V90M)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
AMMONIA(UNII: 5138Q19F1X)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POLYETHYLENE OXIDE 200000(UNII: 11628IH70O)
POLYETHYLENE OXIDE 900000(UNII: 16P9295IIL)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor	LIME	Imprint Code	A2
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:47781-355-03	30 in 1 CARTON	02/11/2019
1	NDC:47781-355-11	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
ANDA	ANDA205954	02/11/2019

Buprenorphine and Naloxone Buprenorphine and Naloxone FILM

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:47781-356
Route of Administration	SUBLINGUAL, BUCCAL	DEA Schedule	CIII

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUPRENORPHINE HYDROCHLORIDE(UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)	BUPRENORPHINE	4 mg
NALOXONE HYDROCHLORIDE DIHYDRATE(UNII: 5Q187997EE) (NALOXONE - UNII:36B82AMQ7N)	NALOXONE	1 mg

Ingredient Name	Strength
Inactive Ingredients
POLYETHYLENE OXIDE 100000(UNII: V46Y6OJ5QB)
MALTITOL(UNII: D65DG142WK)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
ACESULFAME POTASSIUM(UNII: 23OV73Q5G9)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
ALCOHOL(UNII: 3K9958V90M)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
AMMONIA(UNII: 5138Q19F1X)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POLYETHYLENE OXIDE 200000(UNII: 11628IH70O)
POLYETHYLENE OXIDE 900000(UNII: 16P9295IIL)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor	LIME	Imprint Code	A4
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:47781-356-03	30 in 1 CARTON	02/11/2019
1	NDC:47781-356-11	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
ANDA	ANDA205954	02/11/2019

Buprenorphine and Naloxone Buprenorphine and Naloxone FILM

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:47781-357
Route of Administration	SUBLINGUAL, BUCCAL	DEA Schedule	CIII

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUPRENORPHINE HYDROCHLORIDE(UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)	BUPRENORPHINE	8 mg
NALOXONE HYDROCHLORIDE DIHYDRATE(UNII: 5Q187997EE) (NALOXONE - UNII:36B82AMQ7N)	NALOXONE	2 mg

Ingredient Name	Strength
Inactive Ingredients
POLYETHYLENE OXIDE 100000(UNII: V46Y6OJ5QB)
MALTITOL(UNII: D65DG142WK)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
ACESULFAME POTASSIUM(UNII: 23OV73Q5G9)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
ALCOHOL(UNII: 3K9958V90M)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
AMMONIA(UNII: 5138Q19F1X)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POLYETHYLENE OXIDE 200000(UNII: 11628IH70O)
POLYETHYLENE OXIDE 900000(UNII: 16P9295IIL)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor	LIME	Imprint Code	A8
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:47781-357-03	30 in 1 CARTON	02/11/2019
1	NDC:47781-357-11	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
ANDA	ANDA205954	02/11/2019

Buprenorphine and Naloxone Buprenorphine and Naloxone FILM

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:47781-358
Route of Administration	SUBLINGUAL, BUCCAL	DEA Schedule	CIII

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUPRENORPHINE HYDROCHLORIDE(UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)	BUPRENORPHINE	12 mg
NALOXONE HYDROCHLORIDE DIHYDRATE(UNII: 5Q187997EE) (NALOXONE - UNII:36B82AMQ7N)	NALOXONE	3 mg

Ingredient Name	Strength
Inactive Ingredients
POLYETHYLENE OXIDE 100000(UNII: V46Y6OJ5QB)
MALTITOL(UNII: D65DG142WK)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
ACESULFAME POTASSIUM(UNII: 23OV73Q5G9)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
ALCOHOL(UNII: 3K9958V90M)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
AMMONIA(UNII: 5138Q19F1X)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POLYETHYLENE OXIDE 200000(UNII: 11628IH70O)
POLYETHYLENE OXIDE 900000(UNII: 16P9295IIL)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor	LIME	Imprint Code	A12
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:47781-358-03	30 in 1 CARTON	02/11/2019
1	NDC:47781-358-11	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
ANDA	ANDA205954	02/11/2019

LABELER - Alvogen Inc.(008057330)

NDC 47781-355-03
API & Excipient Details

Buprenorphine Hydrochloride marketed by Alvogen Inc. under NDC Code 47781-355-03

NDC Code(s) : 47781-355-11, 47781-355-03, 47781-356-11, 47781-356-03, 47781-357-11, 47781-357-03, 47781-358-11, 47781-358-03
Packager : Alvogen Inc.

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 47781-355-03 API & Excipient Details

Buprenorphine Hydrochloride marketed by Alvogen Inc. under NDC Code 47781-355-03

NDC Code(s) : 47781-355-11, 47781-355-03, 47781-356-11, 47781-356-03, 47781-357-11, 47781-357-03, 47781-358-11, 47781-358-03Packager : Alvogen Inc.

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 47781-355-03
API & Excipient Details

NDC Code(s) : 47781-355-11, 47781-355-03, 47781-356-11, 47781-356-03, 47781-357-11, 47781-357-03, 47781-358-11, 47781-358-03
Packager : Alvogen Inc.