CEFPROZIL (Page 6 of 6)

REFERENCES

  1. 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.
  2. 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.
  3. 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 Mumbai 400 098

United States INDIA

Revised: December, 2007 ID#: 213043

PRINCIPAL DISPLAY PANEL

CEFPROZIL TABLETS USP

Rx Only

250 mg

NDC 68180-403-01

100 Tablets

CEFPROZIL TABLETS USP
Rx Only
250 mg
NDC 68180-403-01
							100 Tablets
(click image for full-size original)

CEFPROZIL TABLETS USP

Rx Only

500 mg

NDC 68180-404-01

50 Tablets

CEFPROZIL TABLETS USP
Rx Only
500 mg
NDC 68180-404-01
							50 Tablets
(click image for full-size original)
CEFPROZIL cefprozil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-403
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFPROZIL (CEFPROZIL ANHYDROUS) CEFPROZIL ANHYDROUS 250 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6
SODIUM STARCH GLYCOLATE TYPE A POTATO
METHYLCELLULOSE (15 CPS)
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
Product Characteristics
Color ORANGE Score no score
Shape OVAL Size 15mm
Flavor Imprint Code LUPIN;250
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-403-01 100 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
CEFPROZIL cefprozil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-404
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:57297-404-01 50 TABLET in 1 BOTTLE None
2 NDC:57297-404-02 100 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 — LUPIN LIMITED (675923163)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 725504448 manufacture (57297-403), manufacture (57297-404), pack (57297-403), pack (57297-404)

Revised: 05/2016 LUPIN LIMITED

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