Abacavir Sulfate (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — 300 mg

NDC 53808-0627-1

Abacavir
Tablets, USP
300 mg

Notice to Authorized Dispenser:
Each time abacavir tablets are dispensed,
give the patient a Medication Guide and
Warning Card from the carton.

Rx only 30 Tablets

Each film-coated tablet contains
abacavir sulfate, USP equivalent to
300 mg of abacavir.

Usual Dosage: See accompanying
prescribing information.

Keep this and all medication out of the
reach of children.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Abacavir Tablets, USP 300 mg Carton LabelsAbacavir Tablets, USP 300 mg Carton Labels
ABACAVIR SULFATE abacavir sulfate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53808-0627(NDC:0378-4105)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ABACAVIR SULFATE (ABACAVIR) ABACAVIR 300 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
FERRIC OXIDE RED
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color ORANGE (peach) Score 2 pieces
Shape OVAL (capsule-shaped) Size 18mm
Flavor Imprint Code M;120
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53808-0627-1 30 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091294 01/01/2013
Labeler — State of Florida DOH Central Pharmacy (829348114)
Establishment
Name Address ID/FEI Operations
State of Florida DOH Central Pharmacy 829348114 repack (53808-0627)

Revised: 08/2013 State of Florida DOH Central Pharmacy

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