NDC Code(s) : 65862-535-75, 65862-535-13, 65862-535-02
Packager : Aurobindo Pharma Limited

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:65862-535
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS600 mg in 5 mL
CLAVULANATE POTASSIUM(UNII: Q42OMW3AT8)
(CLAVULANIC ACID - UNII:23521W1S24) 		CLAVULANIC ACID42.9 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSE 2910 (50 MPA.S)(UNII: 1IVH67816N)
STRAWBERRY(UNII: 4J2TY8Y81V)
SUCCINIC ACID(UNII: AB6MNQ6J6L)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color WHITE (White to Off-white) Score
Shape Size
Flavor STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65862-535-7575 mL in 1 BOTTLE Type 0: Not a Combination Product20/12/2011
2NDC:65862-535-13125 mL in 1 BOTTLE Type 0: Not a Combination Product20/12/2011
3NDC:65862-535-02200 mL in 1 BOTTLE Type 0: Not a Combination Product20/12/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201091 12/20/2011

LABELER - Aurobindo Pharma Limited(650082092)

Establishment
Name Address ID/FEI Business Operations
Aurobindo Pharma Limited 918917683 ANALYSIS(65862-535), MANUFACTURE(65862-535)

PRINCIPAL DISPLAY PANEL


NDC 65862-535-02
Rx only 
Amoxicillin and
Clavulanate Potassium for
Oral Suspension, USP
600 mg/42.9 mg* per 5 mL
200 mL when reconstituted

AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/42.9 mg* per 5 mL