Ursodiol

Product NDC
50268-796
11-digit product format
502680796
Labeler code
50268
Product ID
50268-796_6e13496f-d95c-eac7-e053-2991aa0aebed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ursodiol
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA075517
Marketing category
ANDA
Marketing start
2012-07-25
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
50268-796-11EA - Each50268-796a716dd07-0002-42fd-8c08-393617986e9512015-05-05
50268-796-15EA - Each50268-796bfceec2a-6949-4e74-9be5-ccf528c7314d12013-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-796-155026807961550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-796-15) > 1 CAPSULE in 1 BLISTER PACK (50268-796-11) 50 blister pack2012-07-250000-00-00NoNoCurrent