Amoxicillin and Clavulanate Potassium (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

Amoxicillin and Clavulanate Potassium

Tablets, USP

875 mg/125 mg*

Rx only

72789253 label
(click image for full-size original)
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin and clavulanate potassium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72789-253(NDC:0143-9249)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 875 mg
CLAVULANATE POTASSIUM (CLAVULANIC ACID) CLAVULANIC ACID 125 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
ETHYLCELLULOSES
HYPROMELLOSES
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
PROPYLENE GLYCOL
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color white Score 2 pieces
Shape CAPSULE Size 22mm
Flavor Imprint Code WW949
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72789-253-20 20 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203824 08/23/2016
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (72789-253)

Revised: 02/2024 PD-Rx Pharmaceuticals, Inc.

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