CEFPROZIL (Page 6 of 6)

REFERENCES

  • National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically -Third Edition. Approved Standard NCCLS Document M7-A3, Vol.13, No. 25, NCCLS, Villanova, PA, December 1993.
  • National Committee for Clinical Laboratory Standards. Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria -Third Edition. Approved Standard NCCLS Document M11-A3, Vol. 13, No. 26, NCCLS, Villanova, PA, December 1993.
  • National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests -Fifth Edition. Approved Standard NCCLS Document M2-A5, Vol. 13, No. 24, NCCLS, Villanova, PA, December 1993.

Clintest® and Clinistix® are registered trademarks of Bayer HealthCare LLC.

Manufactured for: Manufactured by

Lupin Pharmaceuticals, Inc. Lupin Limited

Baltimore, Maryland 21202 Mandideep 462046

United States INDIA

Revised: January 2017 ID#: 250340

Principal Display Panel

Image Description
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SPL Image

CEFPROZIL cefprozil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53217-031(NDC:68180-404)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFPROZIL (CEFPROZIL ANHYDROUS) CEFPROZIL ANHYDROUS 500 mg
Inactive Ingredients
Ingredient Name Strength
SODIUM STARCH GLYCOLATE TYPE A POTATO
METHYLCELLULOSE (15 CPS)
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 18mm
Flavor Imprint Code LUPIN;500
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53217-031-20 20 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065276 12/01/2005
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 03/2017 Aidarex Pharmaceuticals LLC

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