Ursodiol - 51079-383-20 - (ursodiol)

Alphabetical Index


Drug Information of Ursodiol

Product NDC: 51079-383
Proprietary Name: Ursodiol
Non Proprietary Name: ursodiol
Active Ingredient(s): 300    mg/1 & nbsp;   ursodiol
Administration Route(s): ORAL
Dosage Form(s): CAPSULE
Coding System: National Drug Codes(NDC)

Labeler Information of Ursodiol

Product NDC: 51079-383
Labeler Name: UDL Laboratories, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA090530
Marketing Category: ANDA
Start Marketing Date: 20100527

Package Information of Ursodiol

Package NDC: 51079-383-20
Package Description: 100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-383-20) > 1 CAPSULE in 1 BLISTER PACK (51079-383-01)

NDC Information of Ursodiol

NDC Code 51079-383-20
Proprietary Name Ursodiol
Package Description 100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-383-20) > 1 CAPSULE in 1 BLISTER PACK (51079-383-01)
Product NDC 51079-383
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name ursodiol
Dosage Form Name CAPSULE
Route Name ORAL
Start Marketing Date 20100527
Marketing Category Name ANDA
Labeler Name UDL Laboratories, Inc.
Substance Name URSODIOL
Strength Number 300
Strength Unit mg/1
Pharmaceutical Classes Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient]

Complete Information of Ursodiol


General Information