FDA.reportPublic FDA data

Lubiprostone

Product NDC
42291-475
11-digit product format
422910475
Labeler code
42291
Product ID
42291-475_f1763c5a-5f35-fac0-e053-2995a90a038a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lubiprostone
Dosage form
CAPSULE
Route
ORAL
Labeler
AvKARE
Application
ANDA209450
Marketing category
ANDA
Marketing start
2023-01-04
Marketing end
0000-00-00
Substance
LUBIPROSTONE
Active strength
8 ug/1
Pharmacologic classes
Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3b517f14-6449-952f-8aaf-98f2ec9051d0Product name320251024

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42291-475-602026-01-29C16284748780-149896155-c6e8-586f-e063-e6dba90add90Lubiprostone Capsules Rx Only These highlights do not include all the information needed to use LUBIPROSTONE CAPSULES, safely and effectively. See full prescribing information for LUBIPROSTONE CAPSULES. Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-475-60Lubiprostone60 in 1 BOTTLECAPSULE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-475-60EA - Each42291-47597cb7874-7194-4e37-b627-20d91d53b76612023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-475LUBIPROSTONE CAPSULE [AVKARE]2Legacy NDC, 1 package rows20230325_f1763c5a-5f36-fac0-e053-2995a90a038a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616578lubiprostone 24 MCG Oral CapsulePSNf1763c5a-5f36-fac0-e053-2995a90a038a2
794639lubiprostone 8 MCG Oral CapsulePSNf1763c5a-5f36-fac0-e053-2995a90a038a2
794639lubiprostone 0.008 MG Oral CapsuleSCDf1763c5a-5f36-fac0-e053-2995a90a038a2
616578lubiprostone 0.024 MG Oral CapsuleSCDf1763c5a-5f36-fac0-e053-2995a90a038a2
616578lubiprostone 24 MCG Oral CapsuleSYf1763c5a-5f36-fac0-e053-2995a90a038a2
794639lubiprostone 8 MCG Oral CapsuleSYf1763c5a-5f36-fac0-e053-2995a90a038a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-475-604229104756060 CAPSULE in 1 BOTTLE (42291-475-60) 60 capsule2023-01-040000-00-00NoNoCurrent