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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42291-475IInactivated by FDA2026-08-03
excluded packagepackage42291-47542291-475-60IInactivated by FDA2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209450-001LUBIPROSTONELUBIPROSTONE8MCGCAPSULE / ORALAB2021-11-30
A209450-002LUBIPROSTONELUBIPROSTONE24MCGCAPSULE / ORALAB2021-11-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A209450-001AB
A209450-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A209450-001LUBIPROSTONE8MCGCAPSULE / ORALAB2021-11-30a50c72e98297…
2026-08-01 22:54:322026-06A209450-002LUBIPROSTONE24MCGCAPSULE / ORALAB2021-11-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209450-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A209450-002AB1a50c72e98297…

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