URSODEOXYCHOLIC ACID POWDER [AX PHARMACEUTICAL CORP]

URSODEOXYCHOLIC ACID POWDER [AX PHARMACEUTICAL CORP]
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NDC	62157-778-01
Set ID	91103297-3b8a-4d56-9ee6-c14ac3e7efe6
Category	BULK INGREDIENT
Packager	AX Pharmaceutical Corp
Generic Name
Product Class
Product Number
Application Number

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Product label

INGREDIENTS AND APPEARANCE

URSODEOXYCHOLIC ACID
ursodeoxycholic acid powder

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC:62157-778
Route of Administration	NOT APPLICABLE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
URSODIOL (UNII: 724L30Y2QR) (URSODIOL - UNII:724L30Y2QR)	URSODIOL	1 kg in 1 kg

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62157-778-01	25 kg in 1 DRUM	02/04/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
bulk ingredient for animal drug compounding		02/04/2019

Labeler - AX Pharmaceutical Corp (202924858)

Name	Address	ID/FEI	Business Operations
Establishment
Zhongshan Belling Biothechnology Co., Ltd.		528104186	manufacture(62157-778)

Name	Address	ID/FEI	Business Operations
Establishment
AX Pharmaceutical Corp		202924858	relabel(62157-778) , repack(62157-778)

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