FDA.reportPublic FDA data

Lubiprostone

Product NDC
51407-745
11-digit product format
514070745
Labeler code
51407
Product ID
51407-745_4f9bf5e1-b740-7d98-e063-6294a90afaed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lubiprostone
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
NDA021908
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2006-01-31
Substance
LUBIPROSTONE
Active strength
24 ug/1
Pharmacologic classes
Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lubiprostone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LUBIPROSTONE24 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7662KG2R6K
Rxcui616578, 794639

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-745-60Lubiprostone60 in 1 BOTTLECAPSULE, GELATIN COATED605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-745-60EA - Each51407-74538f7287f-1602-4566-b7d5-e3fe60d4066812023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-745LUBIPROSTONE CAPSULE, GELATIN COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]4Current NDC, 1 package rows20250424_f4d506e0-1322-4fc4-e053-2995a90ac880.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616578lubiprostone 24 MCG Oral CapsulePSNf4d506e0-1322-4fc4-e053-2995a90ac8805
794639lubiprostone 8 MCG Oral CapsulePSNf4d506e0-1322-4fc4-e053-2995a90ac8805
794639lubiprostone 0.008 MG Oral CapsuleSCDf4d506e0-1322-4fc4-e053-2995a90ac8805
616578lubiprostone 0.024 MG Oral CapsuleSCDf4d506e0-1322-4fc4-e053-2995a90ac8805
616578lubiprostone 24 MCG Oral CapsuleSYf4d506e0-1322-4fc4-e053-2995a90ac8805
794639lubiprostone 8 MCG Oral CapsuleSYf4d506e0-1322-4fc4-e053-2995a90ac8805

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51407-745-605140707456060 CAPSULE, GELATIN COATED in 1 BOTTLE (51407-745-60) 2023-01-23NoNoCurrent