NDC Code(s) : 65862-751-50, 65862-751-01, 65862-752-50, 65862-752-75
Packager : Aurobindo Pharma Limited

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cefixime cefixime POWDER, FOR SUSPENSION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:65862-751
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFIXIME(UNII: 97I1C92E55)
(CEFIXIME ANHYDROUS - UNII:XZ7BG04GJX) 		CEFIXIME ANHYDROUS100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STRAWBERRY(UNII: 4J2TY8Y81V)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color WHITE (Off-white to pale yellow) Score
Shape Size
Flavor STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65862-751-5050 mL in 1 BOTTLE Type 0: Not a Combination Product14/04/2015
2NDC:65862-751-01100 mL in 1 BOTTLE Type 0: Not a Combination Product14/04/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204835 04/14/2015
Cefixime cefixime POWDER, FOR SUSPENSION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:65862-752
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFIXIME(UNII: 97I1C92E55)
(CEFIXIME ANHYDROUS - UNII:XZ7BG04GJX) 		CEFIXIME ANHYDROUS200 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STRAWBERRY(UNII: 4J2TY8Y81V)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color WHITE (Off-white to pale yellow) Score
Shape Size
Flavor STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65862-752-5050 mL in 1 BOTTLE Type 0: Not a Combination Product14/04/2015
2NDC:65862-752-7575 mL in 1 BOTTLE Type 0: Not a Combination Product14/04/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204835 04/14/2015

LABELER - Aurobindo Pharma Limited(650082092)

Establishment
Name Address ID/FEI Business Operations
Aurobindo Pharma Limited 918917639 ANALYSIS(65862-751, 65862-752), MANUFACTURE(65862-751, 65862-752)

PRINCIPAL DISPLAY PANEL

NDC 65862-751-50
Rx only
Cefixime for
Oral Suspension, USP
100 mg/5 mL
when reconstituted
FOR ORAL USE ONLY
SHAKE WELL BEFORE USING
AUROBINDO              50 mL
                     (when reconstituted)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg/5 mL (50 mL Bottle)

PRINCIPAL DISPLAY PANEL

NDC 65862-752-50
Rx only
Cefixime for
Oral Suspension, USP
200 mg/5 mL
when reconstituted
FOR ORAL USE ONLY
SHAKE WELL BEFORE USING
AUROBINDO            50 mL
                  (when reconstituted)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/5 mL (50 mL Bottle)