Allopurinol (Page 4 of 4)

HOW SUPPLIED

100 mg white to off-white colored, round, beveled edged uncoated tablets with “RG10 ” embossed on one side and breakline on the other side.

The tablets are supplied in the following package sizes:

Bottles of 100 tablets NDC 63304-539-01

Bottles of 1000 tablets NDC 63304-539-10

300 mg peach colored, round, beveled edged uncoated tablets with “RG11 ” embossed on one side and breakline on the other side.

The tablets are supplied in the following package sizes:

Bottles of 100 tablets NDC 63304-540-01

Bottles of 500 tablets NDC 63304-540-05

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

You may report side effects to FDA at 1-800-FDA-1088.

Manufactured for:

Ranbaxy Pharmaceuticals Inc.

Jacksonvilla, FL 32257 USA

by: Ipca Laboratories Limited

48, Kandivli Ind Estate, Mumbai 400 067, India

November 2011

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ranbaxy

NDC 63304-539-10

Allopurinol

Tablets, USP

100 mg

Rx only

1000 Tablets

Ranbaxy

NDC 63304-540-05

Allopurinol

Tablets, USP

300 mg

Rx only

500 Tablets

ALLOPURINOL allopurinol tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-539 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLOPURINOL (ALLOPURINOL) ALLOPURINOL 100 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE POVIDONE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN STEARIC ACID FD&C YELLOW NO. 6

Product Characteristics Color WHITE (white to off white) Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code RG10 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63304-539-01 100 TABLET in 1 BOTTLE None 2 NDC:63304-539-10 1000 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090637 06/06/2011

ALLOPURINOL allopurinol tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-540 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLOPURINOL (ALLOPURINOL) ALLOPURINOL 300 mg

Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 LACTOSE MONOHYDRATE POVIDONE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN STEARIC ACID

Product Characteristics Color ORANGE (peach) Score 2 pieces Shape ROUND Size 12mm Flavor Imprint Code RG11 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63304-540-05 500 TABLET in 1 BOTTLE None 2 NDC:63304-540-01 100 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090637 06/06/2011

Labeler — Ranbaxy Pharmaceuticals Inc. (937890044)

Registrant — Ipca Laboratories Limited (650387009)

Establishment
Name	Address	ID/FEI	Operations
Ipca Laboratories Limited		918917303	Manufacture (63304-539), Manufacture (63304-540)

Revised: 08/2013 Ranbaxy Pharmaceuticals Inc.