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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPRENORPHINE HYDROCHLORIDE(UNII: 56W8MW3EN1)
(BUPRENORPHINE - UNII:40D3SCR4GZ) 		BUPRENORPHINE2 mg
NALOXONE HYDROCHLORIDE DIHYDRATE(UNII: 5Q187997EE)
(NALOXONE - UNII:36B82AMQ7N) 		NALOXONE0.5 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:47781-355-0330 in 1 CARTON 02/11/2019
1NDC:47781-355-111 in 1 POUCH Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPRENORPHINE HYDROCHLORIDE(UNII: 56W8MW3EN1)
(BUPRENORPHINE - UNII:40D3SCR4GZ) 		BUPRENORPHINE4 mg
NALOXONE HYDROCHLORIDE DIHYDRATE(UNII: 5Q187997EE)
(NALOXONE - UNII:36B82AMQ7N) 		NALOXONE1 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:47781-356-0330 in 1 CARTON 02/11/2019
1NDC:47781-356-111 in 1 POUCH Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPRENORPHINE HYDROCHLORIDE(UNII: 56W8MW3EN1)
(BUPRENORPHINE - UNII:40D3SCR4GZ) 		BUPRENORPHINE8 mg
NALOXONE HYDROCHLORIDE DIHYDRATE(UNII: 5Q187997EE)
(NALOXONE - UNII:36B82AMQ7N) 		NALOXONE2 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:47781-357-0330 in 1 CARTON 02/11/2019
1NDC:47781-357-111 in 1 POUCH Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPRENORPHINE HYDROCHLORIDE(UNII: 56W8MW3EN1)
(BUPRENORPHINE - UNII:40D3SCR4GZ) 		BUPRENORPHINE12 mg
NALOXONE HYDROCHLORIDE DIHYDRATE(UNII: 5Q187997EE)
(NALOXONE - UNII:36B82AMQ7N) 		NALOXONE3 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:47781-358-0330 in 1 CARTON 02/11/2019
1NDC:47781-358-111 in 1 POUCH Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205954 02/11/2019

LABELER - Alvogen Inc.(008057330)

PRINCIPAL DISPLAY PANEL

NDC 47781-355-03

Buprenorphine CIII
and Naloxone
Sublingual Film

2 mg/0.5 mg

Instructions for the Pharmacist: Dispense the enclosed Medication Guide to each patient.

Children who accidentally take Buprenorphine and Naloxone Sublingual Film will need emergency medical care. Keep Buprenorphine and Naloxone Sublingual Film out of the reach of children.

Do not cut, chew or swallow sublingual film.

Rx only

PRINCIPAL DISPLAY PANEL

NDC 47781-355-11

Buprenorphine CIII
and Naloxone
Sublingual Film  

2 mg/0.5 mg  

Children who accidentally take
Buprenorphine and Naloxone Sublingual Film
will need emergency medical care. Keep
Buprenorphine and Naloxone Sublingual Film
out of the reach of children.    

Do not cut, chew or swallow sublingual film.

Rx only  

PRINCIPAL DISPLAY PANEL

NDC 47781-356-03

Buprenorphine CIII
and Naloxone
Sublingual Film  

4 mg/1 mg  

Instructions for the Pharmacist: Dispense the enclosed Medication Guide to each patient.

Children who accidentally take Buprenorphine and Naloxone Sublingual Film will need emergency medical care. Keep Buprenorphine and Naloxone Sublingual Film out of the reach of children.

Do not cut, chew or swallow sublingual film.

Rx only

PRINCIPAL DISPLAY PANEL

NDC 47781-356-11

Buprenorphine CIII
and Naloxone
Sublingual Film  

4 mg/1 mg  

Children who accidentally take
Buprenorphine and Naloxone Sublingual Film
will need emergency medical care. Keep
Buprenorphine and Naloxone Sublingual Film
out of the reach of children.    

Do not cut, chew or swallow sublingual film.

Rx only

PRINCIPAL DISPLAY PANEL

NDC 47781-357-03 

Buprenorphine CIII
and Naloxone
Sublingual Film

8 mg/2 mg  

Instructions for the Pharmacist: Dispense the enclosed Medication Guide to each patient.

Children who accidentally take Buprenorphine and Naloxone Sublingual Film will need emergency medical care. Keep Buprenorphine and Naloxone Sublingual Film out of the reach of children.

Do not cut, chew or swallow sublingual film.

Rx only

PRINCIPAL DISPLAY PANEL

NDC 47781-357-11

Buprenorphine CIII
and Naloxone
Sublingual Film

8 mg/2 mg

Children who accidentally take
Buprenorphine and Naloxone Sublingual Film
will need emergency medical care. Keep
Buprenorphine and Naloxone Sublingual Film
out of the reach of children.

Do not cut, chew or swallow sublingual film.

Rx only

PRINCIPAL DISPLAY PANEL

NDC 47781-358-03   

Buprenorphine CIII
and Naloxone
Sublingual Film   

12 mg/3 mg   

Instructions for the Pharmacist: Dispense the enclosed Medication Guide to each patient.

Children who accidentally take Buprenorphine and Naloxone Sublingual Film will need emergency medical care. Keep Buprenorphine and Naloxone Sublingual Film out of the reach of children.

Do not cut, chew or swallow sublingual film.

Rx only

PRINCIPAL DISPLAY PANEL

NDC 47781-358-11

Buprenorphine CIII
and Naloxone
Sublingual Film

12 mg/3 mg

Children who accidentally take
Buprenorphine and Naloxone Sublingual Film
will need emergency medical care. Keep
Buprenorphine and Naloxone Sublingual Film
out of the reach of children.

Do not cut, chew or swallow sublingual film.

Rx only