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.

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.

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.