FDA.reportPublic FDA data

Lubiprostone

Product NDC
65162-842
Requested package NDC
65162-842-18
11-digit product format
651620842
Labeler code
65162
Product ID
65162-842_46db0194-b960-401e-a885-ccb545b72f51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lubiprostone
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA209450
Marketing category
ANDA
Marketing start
2021-12-03
Marketing end
0000-00-00
Substance
LUBIPROSTONE
Active strength
24 ug/1
Pharmacologic classes
Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage65162-84265162-842-18DDiscontinued by firm2026-07-31

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-842-06EA - Each65162-8423598cfda-f7a4-4228-9cd7-19e639c19c7212023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-842LUBIPROSTONE CAPSULE [AMNEAL PHARMACEUTICALS LLC]22Legacy NDC20241030_333acede-5075-464f-9418-4b22d43eef3c.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
65162-842-1865162084218180 CAPSULE in 1 BOTTLE (65162-842-18) 180 capsule2021-12-030000-00-00NoNoCurrent