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:

Count	300 mg
45	71610-064-45
90	71610-064-60

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:

Cookeville, TN 38506
20220422JK

PRINCIPAL DISPLAY PANEL — 300 mg

NDC 71610-064 — Allopurinol 300 mg — Rx Only

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