NDC Code(s) : 43063-342-03
Packager : PD-Rx 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 TABLET, CHEWABLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-342(NDC:0781-1643)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS400 mg
CLAVULANATE POTASSIUM(UNII: Q42OMW3AT8)
(CLAVULANIC ACID - UNII:23521W1S24) 		CLAVULANIC ACID57 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
BANANA(UNII: 4AJZ4765R9)
CHERRY(UNII: BUC5I9595W)
FD&C RED NO. 40(UNII: WZB9127XOA)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color pink Score no score
Shape ROUND Size 15 mm
Flavor Imprint Code GGN4
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43063-342-033 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product01/12/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065065 04/18/2002

PRINCIPAL DISPLAY PANEL

43063342 Label

NDC 43063-342-03

Amoxicillin and Clavulanate

Potassium Tablets, USP

(Chewable)

400 mg/57 mg*

Rx only

3 Chewable Tablets