Buprenorphine and Naloxone (Page 12 of 12)

PRINCIPAL DISPLAY PANEL 2 mg/0.5 mg 30-count Bottle Label

NDC 60429-586-30

Buprenorphine and Naloxone
Sublingual Tablets 2 mg/0.5 mg

30 Tablets

CIII

Rx only

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Children who accidentally take this drug product will need emergency medical care. Keep out of reach of children.

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PRINCIPAL DISPLAY PANEL 8 mg/2 mg 30-count Bottle Label

NDC 60429-587-30

Buprenorphine and Naloxone
Sublingual Tablets 8 mg/2 mg

30 Tablets

CIII

Rx only

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Children who accidentally take this drug product will need emergency medical care. Keep out of reach of children.

//medlibrary.org/lib/images-rx/buprenorphine-and-naloxone-8/60429-587-30pl-300x221.jpg
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BUPRENORPHINE AND NALOXONE buprenorphine hydrochloride and naloxone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-586(NDC:50383-294)
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 (NALOXONE) NALOXONE 0.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MANNITOL
STARCH, CORN
POVIDONE K30
WATER
ANHYDROUS CITRIC ACID
SODIUM CITRATE, UNSPECIFIED FORM
SODIUM STEARYL FUMARATE
ACESULFAME POTASSIUM
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND (round, biconvex) Size 7mm
Flavor LEMON (lemon flavor) , LIME (lime flavor) Imprint Code N2;Up;Arrow
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-586-30 30 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204431 10/16/2015
BUPRENORPHINE AND NALOXONE buprenorphine hydrochloride and naloxone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-587(NDC:50383-287)
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 (NALOXONE) NALOXONE 2 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MANNITOL
STARCH, CORN
POVIDONE K30
WATER
ANHYDROUS CITRIC ACID
SODIUM CITRATE, UNSPECIFIED FORM
SODIUM STEARYL FUMARATE
ACESULFAME POTASSIUM
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND (round, biconvex) Size 11mm
Flavor LEMON (lemon flavor) , LIME (lime flavor) Imprint Code N8;Up;Arrow
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-587-30 30 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204431 10/16/2015
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Ethypharm 278800789 relabel (60429-587), repack (60429-587), relabel (60429-586), repack (60429-586)

Revised: 06/2021 Golden State Medical Supply, Inc.

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