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

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