ZIAGEN- abacavir sulfate tablet, film coated 
Glaxo Operations UK Ltd

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PRINCIPAL DISPLAY PANEL

NDC 49702-221-18

ZIAGEN ®

(abacavir)

TABLETS

300 mg

Rx only

Notice to Authorized Dispenser:

Each time ZIAGEN is dispensed, give the patient a Medication Guide and Warning Card from the carton.

60 Tablets

 
10000000146300 Rev. 5/17
Ziagen 300 mg tablets 60 count carton
ZIAGEN 
abacavir sulfate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63379-041
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ABACAVIR SULFATE (UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS) ABACAVIR300 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorYELLOWScore2 pieces
ShapeOVAL (Capsule-shaped) Size18mm
FlavorImprint Code GX;623
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63379-041-0160 in 1 BOTTLE; Type 0: Not a Combination Product12/29/1998
2NDC:63379-041-006 in 1 DOSE PACK12/29/1998
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA02097712/29/1998
Labeler - Glaxo Operations UK Ltd (424738227)

Revised: 12/2017
Document Id: 41f8cec6-b1d5-43fb-b3bd-177203857b7c
Set id: bccb1c39-3221-4ec3-801e-ccd275963d01
Version: 2
Effective Time: 20171211
 
Glaxo Operations UK Ltd