Ursodiol 200 mg

Product NDC
0722-7143
11-digit product format
007227143
Labeler code
0722
Product ID
0722-7143_4c90708e-d895-44c4-8ba2-88478fe2e01b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Usodiol
Dosage form
CAPSULE
Route
ORAL
Labeler
Nexgen Pharma, Inc
Application
ANDA205789
Marketing category
ANDA
Marketing start
2020-07-01
Marketing end
0000-00-00
Substance
URSODIOL
Active strength
200 mg/1
Pharmacologic classes
Bile Acid [EPC],Bile Acids and Salts [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ab35ce6-695f-4d1d-43b4-c16fd63c1674Product name320250317
74e0d644-a165-40ec-b881-1b01c8aa68a4Product name120201006
24881a03-c677-697f-03b9-66e93689fadeProduct name220180724

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0722-7143-012021-07-23C16284748780-1c7ccaba7-2940-fd44-e053-dadaa90aa01bUrsodiol Capsules, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0722-7143-01Ursodiol 200 mg100 in 1 BOTTLECAPSULE1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0722-7143URSODIOL 200 MG (USODIOL) CAPSULE URSODIOL 400 MG (USODIOL) CAPSULE [NEXGEN PHARMA, INC]5Legacy NDC, 1 package rows20200701_a0289352-0e73-41d9-9480-a8c2ff5dbf12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
412174ursodiol 200 MG Oral CapsulePSNa0289352-0e73-41d9-9480-a8c2ff5dbf125
2376942ursodiol 400 MG Oral CapsulePSNa0289352-0e73-41d9-9480-a8c2ff5dbf125
412174ursodiol 200 MG Oral CapsuleSCDa0289352-0e73-41d9-9480-a8c2ff5dbf125
2376942ursodiol 400 MG Oral CapsuleSCDa0289352-0e73-41d9-9480-a8c2ff5dbf125

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0722-7143-0100722714301100 CAPSULE in 1 BOTTLE (0722-7143-01) 100 capsule2020-07-010000-00-00NoNoCurrent