NDC Code(s) : 65862-218-60, 65862-218-01, 65862-219-60, 65862-219-01
Packager : Aurobindo Pharma Limited

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cefdinir Cefdinir POWDER, FOR SUSPENSION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:65862-218
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFDINIR(UNII: CI0FAO63WC)
(CEFDINIR - UNII:CI0FAO63WC) 		CEFDINIR125 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE(UNII: C151H8M554)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
XANTHAN GUM(UNII: TTV12P4NEE)
GUAR GUM(UNII: E89I1637KE)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (Off-white to Yellowish) Score
Shape Size
Flavor STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65862-218-601 in 1 CARTON 14/12/2007
160 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:65862-218-011 in 1 CARTON 14/12/2007
2100 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065473 12/14/2007
Cefdinir Cefdinir POWDER, FOR SUSPENSION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:65862-219
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFDINIR(UNII: CI0FAO63WC)
(CEFDINIR - UNII:CI0FAO63WC) 		CEFDINIR250 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE(UNII: C151H8M554)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
XANTHAN GUM(UNII: TTV12P4NEE)
GUAR GUM(UNII: E89I1637KE)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (Off-white to Yellowish) Score
Shape Size
Flavor STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65862-219-601 in 1 CARTON 14/12/2007
160 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:65862-219-011 in 1 CARTON 14/12/2007
2100 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065473 12/14/2007

LABELER - Aurobindo Pharma Limited(650082092)

Establishment
Name Address ID/FEI Business Operations
Aurobindo Pharma Limited 918917639 ANALYSIS(65862-218, 65862-219), MANUFACTURE(65862-218, 65862-219)

PRINCIPAL DISPLAY PANEL


NDC 65862-218-60
Rx only
Cefdinir for Oral
Suspension, USP 
125 mg/5 mL
SHAKE WELL BEFORE USING.
Keep bottle tightly closed.
Any unused portion must bediscarded
10 days after mixing.
RECONSTITUTE WITH 38 mL WATER
60 mL when reconstituted
AUROBINDO


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 125 mg/5 mL (60 mL Bottle)

PRINCIPAL DISPLAY PANEL


Rx only                  NDC 65862-218-60
Cefdinir for Oral
Suspension, USP 
125 mg/5 mL
SHAKE WELL BEFORE USING.
Keep bottle tightly closed.
Any unused portion must be
discarded 10 days after mixing.
RECONSTITUTE WITH
38 mL WATER
60 mL when reconstituted
AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 125 mg/5 mL (60 mL) Carton Label

PRINCIPAL DISPLAY PANEL


NDC 65862-219-60
Rx only
Cefdinir for Oral
Suspension, USP 
250 mg/5 mL
SHAKE WELL BEFORE USING.
Keep bottle tightly closed.
Any unused portion must be discarded
10 days after mixing.
RECONSTITUTE WITH 38 mL WATER
60 mL
when reconstituted
AUROBINDO


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/5 mL (60 mL Bottle)

PRINCIPAL DISPLAY PANEL


Rx only                  NDC 65862-219-60
Cefdinir for Oral
Suspension, USP 
250 mg/5 mL
SHAKE WELL BEFORE USING.
Keep bottle tightly closed.
Any unused portion must be
discarded 10 days after mixing.
RECONSTITUTE WITH
38 mL WATER
60 mL
when reconstituted
AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/5 mL (60 mL) Carton Label