Lubiprostone

Product NDC
65162-841
11-digit product format
651620841
Labeler code
65162
Product ID
65162-841_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
8 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

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
65162-841-06EA - Each65162-8419470d9d0-3253-4c20-8f2a-22175d71a2ed12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-841LUBIPROSTONE 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
65162-841-066516208410660 CAPSULE in 1 BOTTLE (65162-841-06) 60 capsule2021-12-030000-00-00NoNoCurrent
65162-841-1865162084118180 CAPSULE in 1 BOTTLE (65162-841-18) 180 capsule2021-12-030000-00-00NoNoCurrent