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

Principal Display Panel

Allopurinol Tablets, USP 100mg
30 Tablets
NDC 10544-545-30

Principal Display Panel

Allopurinol Tablets, USP 300mg
30 Tablets
NDC 10544-547-30

ALLOPURINOL allopurinol tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-545(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:10544-545-30 30 TABLET in 1 BOTTLE None 2 NDC:10544-545-90 90 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090637 10/07/2013

ALLOPURINOL allopurinol tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-547(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 LACTOSE MONOHYDRATE POVIDONE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN STEARIC ACID FD&C YELLOW NO. 6

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:10544-547-30 30 TABLET in 1 BOTTLE None 2 NDC:10544-547-90 90 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090637 10/07/2013

Labeler — Blenheim Pharmacal, Inc. (171434587)

Registrant — Blenheim Pharmacal, Inc. (171434587)

Establishment
Name	Address	ID/FEI	Operations
Blenheim Pharmacal, Inc.		171434587	repack (10544-545), repack (10544-547)

Revised: 08/2015 Blenheim Pharmacal, Inc.