NDC Code(s) : 67046-992-30, 67046-993-30
Packager : Contract Pharmacy Services-PA

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BuprenorphineBuprenorphine Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67046-992(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(UNII: 2S7830E561)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
ALUMINUM OXIDE(UNII: LMI26O6933)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
STARCH, CORN(UNII: O8232NY3SJ)
POVIDONE(UNII: FZ989GH94E)
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:67046-992-3030 in 1 BLISTER PACK Type 0: Not a Combination Product09/08/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090819 04/10/2015
BuprenorphineBuprenorphine Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67046-993(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(UNII: 2S7830E561)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
ALUMINUM OXIDE(UNII: LMI26O6933)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
STARCH, CORN(UNII: O8232NY3SJ)
POVIDONE(UNII: FZ989GH94E)
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:67046-993-3030 in 1 BLISTER PACK Type 0: Not a Combination Product09/08/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090819 04/10/2015

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 0228-3156-03
Buprenorphine
Sublingual Tablets
2 mg
30 Tablets
Rx Only

PRINCIPAL DISPLAY PANEL NDC 0228-3156-03 Buprenorphine Sublingual Tablets 2 mg 30 Tablets Rx Only

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 0228-3153-03
Buprenorphine
Sublingual Tablets
8 mg
30 Tablets
Rx Only

PRINCIPAL DISPLAY PANEL NDC 0228-3153-03 Buprenorphine Sublingual Tablets 8 mg 30 Tablets Rx Only