NDC Code(s) : 58118-0177-8, 58118-0176-8
Packager : Clinical Solutions Wholesale, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Buprenorphine HClBuprenorphine HCl TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-0177(NDC:0054-0177)
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)
STARCH, CORN(UNII: O8232NY3SJ)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color white Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code 54;411
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58118-0177-830 in 1 BLISTER PACK Type 0: Not a Combination Product15/10/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078633 10/08/2009
Buprenorphine HClBuprenorphine HCl TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-0176(NDC:0054-0176)
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)
STARCH, CORN(UNII: O8232NY3SJ)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color white Score no score
Shape ROUND Size 13 mm
Flavor Imprint Code 54;775
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58118-0176-830 in 1 BLISTER PACK Type 0: Not a Combination Product15/10/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078633 10/08/2009

LABELER - Clinical Solutions Wholesale, LLC(078710347)

REGISTRANT - Clinical Solutions Wholesale, LLC(078710347)

Establishment
Name Address ID/FEI Business Operations
Clinical Solutions Wholesale, LLC 078710347 repack(58118-0176, 58118-0177)

PRINCIPAL DISPLAY PANEL

Buprenorphine 2mg SL Tablets 30 count blister card

PRINCIPAL DISPLAY PANEL

Buprenorphine 8mg SL Tablets 30 count blister card