Mercaptopurine (Page 3 of 3)

HOW SUPPLIED

Light yellow to off white, diamond shaped, scored tablets containing 50 mg mercaptopurine, debossed with “P02 ”; bottles of 60 (NDC 49884-922-02), and 250 (NDC 49884-922-04).

Store at 20° to 25°C (68°to 77°F) in a dry place. See USP controlled room temperature.

REFERENCES

1.
ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburgh, PA: Oncology Nursing Society; 1999:32-41.
2.
Recommendations for the safe handling of parenteral antineoplastic drugs. Washington, DC: Division of Safety; Clinical Center Pharmacy Department and Cancer Nursing Services, National Institutes of Health; 1992. US Dept of Health and Human Services. Public Health Service publication NIH 92-2621.
3.
AMA Council on Scientific Affairs. Guidelines for handling parenteral antineoplastics. JAMA. 1985; 253:1590-1591.
4.
National Study Commission on Cytotoxic Exposure. Recommendations for handling cytotoxic agents. 1987. Available from Louis P. Jeffrey, Chairman, National Study Commission on Cytotoxic Exposure. Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115.
5.
Clinical Oncological Society of Australia. Guidelines and recommendations for safe handling of antineoplastic agents. Med J Australia. 1983; 1:426-428.
6.
Jones RB, Frank R, Mass T. Safe handling of chemotherapeutic agents: a report from the Mount Sinai Medical Center. CA-A Cancer J for Clinicians. 1983;33:258-263.
7.
American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm. 1990;47:1033-1049.
8.
Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines.) Am J Health-Syst Pharm. 1996;53:1669-1685.

Distributed by:
PAR PHARMACEUTICAL COMPANIES, INC.
Spring Valley, NY 10977

ZYLOPRIM® is a registered trademark of Prometheus Laboratories Inc.

Revised: 05/12
OS922-02-1-06
MR001C

Principal Display Panel

50mg 60 tablets bottle

NDC 49884-922-02
Mercaptopurine Tablets,
USP
50 mg
Rx only
Cytotoxic agent
60 Tablets
Par Pharmaceutical

Principal Display Panel -- 50mg 60 tablets bottle
(click image for full-size original)
MERCAPTOPURINE
mercaptopurine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-922
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
mercaptopurine (MERCAPTOPURINE ANHYDROUS) mercaptopurine 50 mg
Inactive Ingredients
Ingredient Name Strength
cellulose, microcrystalline
lactose
stearic acid
silicon dioxide
Product Characteristics
Color YELLOW (YELLOW) Score 2 pieces
Shape DIAMOND (DIAMOND) Size 12mm
Flavor Imprint Code P02
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-922-02 60 TABLET in 1 BOTTLE None
2 NDC:49884-922-04 250 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040461 02/11/2004
Labeler — Par Pharmaceutical Inc. (092733690)
Registrant — Par Pharmaceutical Inc. (092733690)
Establishment
Name Address ID/FEI Operations
Stason Pharmaceuticals, Inc. 807437553 MANUFACTURE (49884-922)

Revised: 01/2015 Par Pharmaceutical Inc.

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