ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

NDC 68180-286-07

ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLETS

300 mg 150 mg 300 mg

Rx only

Notice to Authorized Dispenser:

Dispense drug product with Medication Guide and Warning Card from the carton.

Each tablet contains abacavir sulfate USP equivalent to 300 mg of abacavir, 150 mg of lamivudine USP, and 300 mg of zidovudine USP.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature).

See prescribing information for dosage information.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Pithampur (M.P.) — 454 775

INDIA

NDC 68180-286-07

ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLETS 
300 mg 150 mg 300 mg
TABLETS
Rx only
			Bottle Label: 60 Tablets
(click image for full-size original)
NDC 68180-286-07

ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLETS 
300 mg 150 mg 300 mg
TABLETS
Rx only
			Carton Label: 60 Tablets
(click image for full-size original)
ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE abacavir sulfate, lamivudine and zidovudine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-286
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMIVUDINE (LAMIVUDINE) LAMIVUDINE 150 mg
ZIDOVUDINE (ZIDOVUDINE) ZIDOVUDINE 300 mg
ABACAVIR SULFATE (ABACAVIR) ABACAVIR 300 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 2
FERRIC OXIDE YELLOW
POLYVINYL ALCOHOL
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
POVIDONE
TALC
MAGNESIUM STEARATE
POLYETHYLENE GLYCOLS
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (blue-green) Score no score
Shape OVAL (oval-shaped) Size 22mm
Flavor Imprint Code LU;N51
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-286-07 1 BOTTLE in 1 CARTON contains a BOTTLE
1 60 TABLET in 1 BOTTLE This package is contained within the CARTON (57297-286-07)
2 NDC:57297-286-01 1 BOTTLE in 1 CARTON contains a BOTTLE
2 100 TABLET in 1 BOTTLE This package is contained within the CARTON (57297-286-01)
3 NDC:57297-286-02 1 BOTTLE in 1 CARTON contains a BOTTLE
3 500 TABLET in 1 BOTTLE This package is contained within the CARTON (57297-286-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202912 12/17/2013
Labeler — LUPIN LIMITED (675923163)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 863645527 manufacture (57297-286), pack (57297-286)

Revised: 05/2016 LUPIN LIMITED

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