Allopurinol (Page 5 of 5)

HOW SUPPLIED

Allopurinol Tablets, USP; 100 mg, round, flat, off-white, scored tablet, debossed ‘0524’ over ‘0405’.

Bottles of 100 NDC 55111-729-01

Bottles of 1000 NDC 55111-729-10

300 mg; round, convex, off-white tablet, debossed ‘AL3’.

Bottles of 100 NDC 55111-730-01

Bottles of 500 NDC 55111-730-05

Bottles of 1000 NDC 55111-730-10

Store at 15°-30°C (59°-86°F) and protect from moisture.

QUESTIONS OR COMMENTS? Call toll free 1-888-375-3784.You may report side effects to FDA at 1-800-FDA-1088.

Rx Only

Manufactured by
Dr. Reddy’s Laboratories Louisiana, LLC

Shreveport, LA 71106 USA

Issued August, 2014

150019989-03

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma — TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count300 mg
4571610-064-45
9071610-064-60

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions -- TN
Cookeville, TN 38506
20220422JK

PRINCIPAL DISPLAY PANEL — 300 mg

NDC 71610-064 — Allopurinol 300 mg — Rx Only

Bottle Label 300 mg
(click image for full-size original)

ALLOPURINOL
allopurinol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71610-064(NDC:55111-730)
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
Magnesium stearate
Lactose
povidone
STARCH, CORN
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 11mm
Flavor Imprint Code AL3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71610-064-45 45 TABLET in 1 BOTTLE None
2 NDC:71610-064-60 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071587 10/01/2009
Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)
Establishment
Name Address ID/FEI Operations
Aphena Pharma Solutions — Tennessee, LLC 128385585 REPACK (71610-064)

Revised: 05/2022 Aphena Pharma Solutions — Tennessee, LLC

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