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

allopurinol-03
(click image for full-size original)

Ranbaxy

NDC 63304-540-05

Allopurinol

Tablets, USP

300 mg

Rx only

500 Tablets

allpurinol-04
(click image for full-size original)
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.

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