Lubiprostone

Product NDC
60687-827
11-digit product format
606870827
Labeler code
60687
Product ID
60687-827_4dc7a17c-dac7-1755-e063-6294a90aa2e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lubiprostone
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA209920
Marketing category
ANDA
Marketing start
2025-11-26
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
60687-827-32Lubiprostone20 in 1 CARTONCAPSULE, GELATIN COATED204
60687-827-33Lubiprostone1 in 1 BLISTER PACKCAPSULE, GELATIN COATED14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-827-32EA - Each60687-827fa16de18-f525-44ba-9c02-4674d761820d12025-12-16
60687-827-33EA - Each60687-827055501df-cbf0-4ae1-a0ec-cfe9c3e2aeb712025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616578lubiprostone 24 MCG Oral CapsulePSN3014dd6d-9c05-479d-b79d-7a49f78a1ce54
794639lubiprostone 8 MCG Oral CapsulePSN3014dd6d-9c05-479d-b79d-7a49f78a1ce54
794639lubiprostone 0.008 MG Oral CapsuleSCD3014dd6d-9c05-479d-b79d-7a49f78a1ce54
616578lubiprostone 0.024 MG Oral CapsuleSCD3014dd6d-9c05-479d-b79d-7a49f78a1ce54
616578lubiprostone 24 MCG Oral CapsuleSY3014dd6d-9c05-479d-b79d-7a49f78a1ce54
794639lubiprostone 8 MCG Oral CapsuleSY3014dd6d-9c05-479d-b79d-7a49f78a1ce54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-827-326068708273220 BLISTER PACK in 1 CARTON (60687-827-32) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (60687-827-33) 20 blister pack2025-11-26NoNoHistorical
60687-827-33606870827331 in 1 BLISTER PACKHistorical