AMOXICILLIN TRIHYDRATE AND CLAVULANATE POTASSIUM: Package Insert and Label Information

AMOXICILLIN TRIHYDRATE AND CLAVULANATE POTASSIUM- amoxicillin and clavulanate potassium powder
Shandong New Time Pharmaceutical Co., Ltd.

API LABELER

API LABELER
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AMOXICILLIN TRIHYDRATE AND CLAVULANATE POTASSIUM
amoxicillin trihydrate and clavulanate potassium powder
Product Information
Product Type BULK INGREDIENT Item Code (Source) NDC:42677-108
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN (AMOXICILLIN) AMOXICILLIN 0.8 kg in 1 kg
CLAVULANATE POTASSIUM (CLAVULANIC ACID) CLAVULANIC ACID 0.2 kg in 1 kg
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42677-108-25 25 kg in 1 DRUM None
Image of Product
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Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING 08/04/2020
Labeler — Shandong New Time Pharmaceutical Co., Ltd. (545298254)
Establishment
Name Address ID/FEI Operations
Shandong New Time Pharmaceutical Co., Ltd. 545298254 api manufacture (42677-108)

Revised: 10/2021 Shandong New Time Pharmaceutical Co., Ltd.

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