Allopurinol (Page 5 of 5)

HOW SUPPLIED

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

Bottles of 90 NDC 60429-180-90

Bottles of 100 NDC 60429-180-01

Bottles of 1000 NDC 60429-180-10

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

Bottles of 90 NDC 60429-181-90

Bottles of 100 NDC 60429-181-01

Bottles of 500 NDC 60429-181-05

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

Marketed/Packaged by:
GSMS, Inc.

Camarillo, CA USA 93012

Issued August, 2014

150019989-03

PRINCIPAL DISPLAY PANEL

100 mg Container Label — 9 0’s count

90 Tablets

NDC 60429-180-90

Allopurinol Tablets, USP

100 mg

Rx only

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300 mg Container Label-100’s count

100 Tablets

NDC 60429-181-01

Allopurinol Tablets, USP

300 mg

Rx only

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ALLOPURINOL
allopurinol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-180(NDC:55111-729)
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
MAGNESIUM STEARATE
LACTOSE, UNSPECIFIED FORM
POVIDONE
STARCH, POTATO
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code 0524;0405
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-180-01 100 TABLET in 1 BOTTLE None
2 NDC:60429-180-90 90 TABLET in 1 BOTTLE None
3 NDC:60429-180-10 1000 TABLET in 1 BOTTLE None
4 NDC:60429-180-18 180 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071586 04/02/1987
ALLOPURINOL
allopurinol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-181(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, UNSPECIFIED FORM
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:60429-181-01 100 TABLET in 1 BOTTLE None
2 NDC:60429-181-05 500 TABLET in 1 BOTTLE None
3 NDC:60429-181-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071587 04/02/1987 02/01/2019
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 relabel (60429-180), repack (60429-180), relabel (60429-181), repack (60429-181)

Revised: 01/2020 Golden State Medical Supply, Inc.

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