NDC Code(s) : 0228-3156-03, 0228-3153-03
Packager : Actavis Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BuprenorphineBuprenorphine TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-3156
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
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
STARCH, CORN(UNII: O8232NY3SJ)
POVIDONE K30(UNII: U725QWY32X)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
Product Characteristics
Color orange Score no score
Shape OVAL Size 9 mm
Flavor Imprint Code 156
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0228-3156-0330 in 1 BOTTLE Type 0: Not a Combination Product04/10/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090819 02/19/2015
BuprenorphineBuprenorphine TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-3153
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
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
STARCH, CORN(UNII: O8232NY3SJ)
POVIDONE K30(UNII: U725QWY32X)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
Product Characteristics
Color orange Score no score
Shape OVAL Size 14 mm
Flavor Imprint Code 153
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0228-3153-0330 in 1 BOTTLE Type 0: Not a Combination Product04/10/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090819 02/19/2015

LABELER - Actavis Pharma, Inc.(119723554)

PRINCIPAL DISPLAY PANEL

NDC 0228-3156-03
Buprenorphine Sublingual Tablets 2 mg*   CIII
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
Children who accidentally take buprenorphine will need emergency medical care. Keep out of the reach of children.
Rx only
30 Tablets

2mg new

PRINCIPAL DISPLAY PANEL

NDC 0228-3153-03
Buprenorphine Sublingual Tablets 8 mg*  CIII
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
Children who accidentally take buprenorphine will need emergency medical care. Keep out of the reach of children.
Rx only
30 Tablets

8mgnew