NDC Code(s) : 65862-706-80, 65862-706-01, 65862-706-55, 65862-707-80, 65862-707-01, 65862-707-55
Packager : Aurobindo Pharma Limited

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Amoxicillin Amoxicillin POWDER, FOR SUSPENSION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:65862-706
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS125 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)(UNII: 461P5CJN6T)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
EDETATE DISODIUM(UNII: 7FLD91C86K)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color PINK Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65862-706-8080 mL in 1 BOTTLE Type 0: Not a Combination Product15/09/2014
2NDC:65862-706-01100 mL in 1 BOTTLE Type 0: Not a Combination Product15/09/2014
3NDC:65862-706-55150 mL in 1 BOTTLE Type 0: Not a Combination Product15/09/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204030 09/15/2014
Amoxicillin Amoxicillin POWDER, FOR SUSPENSION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:65862-707
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS250 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)(UNII: 461P5CJN6T)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
EDETATE DISODIUM(UNII: 7FLD91C86K)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color PINK Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65862-707-8080 mL in 1 BOTTLE Type 0: Not a Combination Product15/09/2014
2NDC:65862-707-01100 mL in 1 BOTTLE Type 0: Not a Combination Product15/09/2014
3NDC:65862-707-55150 mL in 1 BOTTLE Type 0: Not a Combination Product15/09/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204030 09/15/2014

LABELER - Aurobindo Pharma Limited(650082092)

Establishment
Name Address ID/FEI Business Operations
Aurobindo Pharma Limited 918917683 ANALYSIS(65862-706, 65862-707), MANUFACTURE(65862-706, 65862-707)

PRINCIPAL DISPLAY PANEL


NDC 65862-706-01

Rx only

Amoxicillin
for Oral Suspension, USP
125 mg per 5 mL

When reconstituted, each 5 mL contains:
AMOXICILLIN, 125 mg as the trihydrate

100 mL (when reconstituted)

AUROBINDO    



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 125 mg/5 mL (100 mL Bottle)

 

PRINCIPAL DISPLAY PANEL


NDC 65862-707-01

Rx only

Amoxicillin
for Oral Suspension, USP
250 mg per 5 mL

When reconstituted, each 5 mL contains:
AMOXICILLIN, 250 mg as the trihydrate

100 mL (when reconstituted)

AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/5 mL (100 mL Bottle)