NDC Code(s) : 68788-0483-7, 68788-0483-1
Packager : Preferred Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-0483(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)
SUCCINIC ACID(UNII: AB6MNQ6J6L)
XANTHAN GUM(UNII: TTV12P4NEE)
STRAWBERRY(UNII: 4J2TY8Y81V)
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:68788-0483-775 mL in 1 BOTTLE Type 0: Not a Combination Product11/07/2011
2NDC:68788-0483-1125 mL in 1 BOTTLE Type 0: Not a Combination Product11/07/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201091 11/07/2011

LABELER - Preferred Pharmaceuticals, Inc.(791119022)

REGISTRANT - Preferred Pharmaceuticals, Inc.(791119022)

Establishment
Name Address ID/FEI Business Operations
Preferred Pharmaceuticals, Inc. 791119022 RELABEL(68788-0483)

PRINCIPAL DISPLAY PANEL

NDC 68788-483
Rx only 
Amoxicillin and
Clavulanate Potassium for
Oral Suspension, USP
600 mg/42.9 mg* per 5 mL
200 mL when reconstituted

AUROBINDO

Relabeled By: Preferred Pharmaceuticals Inc.

Amox. & Clav. Pot. for Oral Susp 600mg/42.9mL