ZYLOPRIM (Page 4 of 4)

HOW SUPPLIED

100-mg (white) scored, flat cylindrical tablets imprinted with “ZYLOPRIM 100” on a raised hexagon, bottles of 100 (NDC 65483-991-10).

Store at 15° to 25°C (59° to 77°F) in a dry place.

300-mg (peach) scored, flat, cylindrical tablets imprinted with “ZYLOPRIM 300” on a raised hexagon, bottles of 100 (NDC 65483-993-10) and 500 (NDC 65483-993-50).

Store at 15° to 25°C (59° to 77°F) in a dry place and protect from light.

PROMETHEUS LABORATORIES INC.
Manufactured by
DSM Pharmaceuticals, Inc.
Greenville, NC 27834
for Prometheus Laboratories Inc.
San Diego, CA 92121

October 2003
ZY004B03

100 mg 100 Tablets Bottle

100 Tablets NDC 65483-991-10

ZYLOPRIM®

(allopurinol)

Each scored tablet contains

100 mg

Rx Only

PROMETHEUS LABORATORIES INC.

Manufactured by DSM Pharmaceuticals, Inc., Greenville, NC 27834

For Prometheus Laboratories Inc., San Diego, CA 92121

October 2003 650392

100 mg 100 Tablets Bottle
(click image for full-size original)

300 mg 100 Tablets Bottle

100 Tablets NDC 65483-993-10

ZYLOPRIM®

(allopurinol)

Each scored tablet contains

300 mg

Rx Only

PROMETHEUS LABORATORIES INC.

Manufactured by DSM Pharmaceuticals, Inc., Greenville, NC 27834

For Prometheus Laboratories Inc., San Diego, CA 92121

October 2003 650390

300 mg 100 Tablets Bottle
(click image for full-size original)
ZYLOPRIM
allopurinol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65483-991
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
magnesium stearate
starch, potato
povidone
Product Characteristics
Color white (white) Score 2 pieces
Shape ROUND (ROUND) Size 3mm
Flavor Imprint Code ZYLOPRIM;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65483-991-10 100 TABLET (100 TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA016084 08/19/1966
ZYLOPRIM
allopurinol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65483-993
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
starch, corn
FD&C Yellow No. 6
lactose
magnesium stearate
starch, potato
povidone
Product Characteristics
Color orange (orange) Score 2 pieces
Shape ROUND (ROUND) Size 4mm
Flavor Imprint Code ZYLOPRIM;300
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65483-993-10 100 TABLET (100 TABLET) in 1 BOTTLE None
2 NDC:65483-993-50 500 TABLET (500 TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA016084 08/19/1966
Labeler — Prometheus Laboratories Inc. (967000860)
Establishment
Name Address ID/FEI Operations
DSM Pharmaceuticals Inc. 076301910 MANUFACTURE

Revised: 11/2009 Prometheus Laboratories Inc.

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.