Ursodiol

Product NDC
55154-3355
11-digit product format
551543355
Labeler code
55154
Product ID
55154-3355_745bac83-0175-4455-b591-6bd5a34ebf11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ursodiol
Dosage form
CAPSULE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA075517
Marketing category
ANDA
Marketing start
2011-04-01
Marketing end
2023-06-30
Substance
URSODIOL
Active strength
300 mg/1
Pharmacologic classes
Bile Acid [EPC], Bile Acids and Salts [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-3355-05515433550010 BLISTER PACK in 1 BAG (55154-3355-0) > 1 CAPSULE in 1 BLISTER PACK10 blister pack2011-04-010000-00-00NoNoCurrent