Ursodiol

Product NDC
51224-151
11-digit product format
512240151
Labeler code
51224
Product ID
51224-151_4d389aa0-ee85-4fb9-b484-c90834778cf9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ursodiol
Dosage form
CAPSULE
Route
ORAL
Labeler
TAGI Pharma, Inc.
Application
ANDA075517
Marketing category
ANDA
Marketing start
2011-04-15
Marketing end
0000-00-00
Substance
URSODIOL
Active strength
300 mg/1
Pharmacologic classes
Bile Acid [EPC],Bile Acids and Salts [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51224-151-50EA - Each51224-15137a29a93-7a7c-4a42-b440-5c1c95d244ba12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51224-151-5051224015150100 CAPSULE in 1 BOTTLE (51224-151-50) 100 capsule2011-04-150000-00-00NoNoCurrent