ABACAVIR AND LAMIVUDINE- abacavir and lamivudine tablet, film coated 
Cadila Healthcare Limited

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ABACAVIR and LAMIVUDINE tablets, for oral use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1053-9

Abacavir and Lamivudine Tablets, 600 mg/300 mg

90 Tablets

Rx only

abacavir sulfate and lamivudine tablet

Abacavir Sulfate and Lamivudine Tablet:

Warning Card

abacavir sulfate and lamivudine tablet
ABACAVIR AND LAMIVUDINE 
abacavir and lamivudine tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1053
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ABACAVIR SULFATE (UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS) ABACAVIR600 mg
LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95) LAMIVUDINE300 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE K30 (UNII: U725QWY32X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorYELLOW (LIGHT YELLOW TO YELLOW) Scoreno score
ShapeCAPSULE (CAPSULE) Size20mm
FlavorImprint Code 1049
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1053-330 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2019
2NDC:70771-1053-990 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20899003/14/2019
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited863362789ANALYSIS(70771-1053) , MANUFACTURE(70771-1053)

Revised: 7/2020
Document Id: be1bb183-637d-4d2d-bfe4-de1450db9083
Set id: 3709b07b-a37d-4ffb-92fa-5c0dd9b973b7
Version: 4
Effective Time: 20200724
 
Cadila Healthcare Limited