NDC Code(s) : 0093-5720-56, 0093-5721-56
Packager : Teva Pharmaceuticals USA, 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:0093-5720
Route of Administration SUBLINGUAL 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
ACESULFAME POTASSIUM(UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
STARCH, CORN(UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
POVIDONE K30(UNII: U725QWY32X)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL (capsule-shaped) Size 7 mm
Flavor LEMON Imprint Code 93;B9
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-5720-5630 in 1 BOTTLE Type 0: Not a Combination Product12/10/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091149 12/10/2014 10/31/2018
Buprenorphine and NaloxoneBuprenorphine and Naloxone TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5721
Route of Administration SUBLINGUAL 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
ACESULFAME POTASSIUM(UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
STARCH, CORN(UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
POVIDONE K30(UNII: U725QWY32X)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 11 mm
Flavor LEMON Imprint Code 93;5721
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-5721-5630 in 1 BOTTLE Type 0: Not a Combination Product12/10/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091149 12/10/2014 10/31/2018

PRINCIPAL DISPLAY PANEL

Buprenorphine and Naloxone Sublingual Tablets 2 mg/0.5 mg CIII 30s Label

PRINCIPAL DISPLAY PANEL

Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg CIII 30s Label