Buprenorphine HCl and Naloxone HCl (Page 11 of 11)

Label — 2mg/0.5mg

2mg
(click image for full-size original)

Label — 8mg/2mg

8mg
(click image for full-size original)

BUPRENORPHINE HCL AND NALOXONE HCL
buprenorphine and naloxone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-144(NDC:65162-416)
Route of Administration SUBLINGUAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE) BUPRENORPHINE 2 mg
NALOXONE HYDROCHLORIDE DIHYDRATE (NALOXONE) NALOXONE 0.5 mg
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM
ANHYDROUS CITRIC ACID
FD&C YELLOW NO. 6
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MANNITOL
POVIDONE
SODIUM CITRATE
STARCH, CORN
Product Characteristics
Color orange Score no score
Shape ROUND Size 6mm
Flavor Imprint Code A;14
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-144-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (50268-144-11)
1 NDC:50268-144-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (50268-144-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203136 12/08/2016
BUPRENORPHINE HCL AND NALOXONE HCL
buprenorphine and naloxone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-145(NDC:65162-415)
Route of Administration SUBLINGUAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE) BUPRENORPHINE 8 mg
NALOXONE HYDROCHLORIDE DIHYDRATE (NALOXONE) NALOXONE 2 mg
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM
ANHYDROUS CITRIC ACID
FD&C YELLOW NO. 6
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MANNITOL
POVIDONE
SODIUM CITRATE
STARCH, CORN
Product Characteristics
Color orange Score no score
Shape ROUND Size 11mm
Flavor Imprint Code AN;415
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-145-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (50268-145-11)
1 NDC:50268-145-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (50268-145-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203136 12/08/2016
Labeler — AvPAK (832926666)

Revised: 03/2020 AvPAK

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