Ursodiol

Product NDC
63629-1173
11-digit product format
636291173
Labeler code
63629
Product ID
63629-1173_043f8ae0-0a19-4bc5-935c-b60422bd3cb1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ursodiol
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212452
Marketing category
ANDA
Marketing start
2020-09-14
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1173URSODIOL CAPSULE [BRYANT RANCH PREPACK]4Legacy NDC20240514_0198041e-9ecd-4f80-8950-39bccaeea155.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1173-163629117301100 CAPSULE in 1 BOTTLE (63629-1173-1) 100 capsule2020-09-140000-00-00NoNoCurrent