NDC Code(s) : 62175-452-32, 62175-458-32
Packager : Lannett Company, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Buprenorphine and NaloxoneBuprenorphine and Naloxone TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62175-452
Route of Administration SUBLINGUAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPRENORPHINE(UNII: 40D3SCR4GZ)
(BUPRENORPHINE - UNII:40D3SCR4GZ) 		BUPRENORPHINE2 mg
NALOXONE(UNII: 36B82AMQ7N)
(NALOXONE - UNII:36B82AMQ7N) 		NALOXONE0.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MANNITOL(UNII: 3OWL53L36A)
CROSPOVIDONE (12 MPA.S AT 5%)(UNII: 40UAA97IT9)
ACESULFAME POTASSIUM(UNII: 23OV73Q5G9)
CITRIC ACID ACETATE(UNII: DSO12WL7AU)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C RED NO. 40(UNII: WZB9127XOA)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
Product Characteristics
Color pink Score no score
Shape HEXAGON (6 sided) Size 2 mm
Flavor LEMON Imprint Code 2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62175-452-3230 in 1 BOTTLE Type 0: Not a Combination Product19/09/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205022 09/19/2016
Buprenorphine and NaloxoneBuprenorphine and Naloxone TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62175-458
Route of Administration SUBLINGUAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPRENORPHINE(UNII: 40D3SCR4GZ)
(BUPRENORPHINE - UNII:40D3SCR4GZ) 		BUPRENORPHINE8 mg
NALOXONE(UNII: 36B82AMQ7N)
(NALOXONE - UNII:36B82AMQ7N) 		NALOXONE2 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MANNITOL(UNII: 3OWL53L36A)
CROSPOVIDONE (12 MPA.S AT 5%)(UNII: 40UAA97IT9)
ACESULFAME POTASSIUM(UNII: 23OV73Q5G9)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CITRIC ACID ACETATE(UNII: DSO12WL7AU)
FD&C RED NO. 40(UNII: WZB9127XOA)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
Product Characteristics
Color pink Score no score
Shape HEXAGON (6 sided) Size 8 mm
Flavor LEMON Imprint Code 8
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62175-458-3230 in 1 BOTTLE Type 0: Not a Combination Product19/09/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205022 09/19/2016

LABELER - Lannett Company, Inc.(006422406)

Establishment
Name Address ID/FEI Business Operations
Lannett Company, Inc. 006422406 analysis(62175-452, 62175-458), label(62175-452, 62175-458), manufacture(62175-452, 62175-458), pack(62175-452, 62175-458)

PRINCIPAL DISPLAY PANEL

NDC 62175-452-32

Buprenorphine 
and Naloxone 
Sublingual Tablets, USP

CIII

2 mg/0.5 mg

Print Medication Guides at: www.lannett.com/med-guide/buprenorphine

Rx Only

30 Tablets

Lannett

label

PRINCIPAL DISPLAY PANEL

NDC 62175-458-32

Buprenorphine 
and Naloxone 
Sublingual Tablets, USP

CIII

8 mg/2 mg

Print Medication Guides at: www.lannett.com/med-guide/buprenorphine

Rx Only

30 Tablets

Lannett

label