Cefadroxil (Page 3 of 3)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 500 mg (50 Capsule Bottle)

NDC 65862-085-50

Rx only

Cefadroxil

Capsules, USP

500 mg

AUROBINDO 50 Capsules

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 500 mg (50 Capsule Bottle)
(click image for full-size original)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 500 mg (50 Capsule Bottle)
CEFADROXIL cefadroxil capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-085
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFADROXIL (CEFADROXIL ANHYDROUS) CEFADROXIL ANHYDROUS 500 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
FD&C BLUE NO. 1
D&C RED NO. 28
FD&C RED NO. 40
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
FERROSOFERRIC OXIDE
Product Characteristics
Color RED (Maroon Opaque) , WHITE (White Opaque) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code C;97
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-085-50 50 CAPSULE in 1 BOTTLE None
2 NDC:65862-085-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065352 01/25/2007
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917639 ANALYSIS (65862-085), MANUFACTURE (65862-085)

Revised: 09/2019 Aurobindo Pharma Limited

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