Lubiprostone

Product NDC
72603-288
11-digit product format
726030288
Labeler code
72603
Product ID
72603-288_4d72c56c-4948-4cd4-afc4-e1e0d59622a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lubiprostone
Dosage form
CAPSULE
Route
ORAL
Labeler
Northstar Rx LLC
Application
ANDA218640
Marketing category
ANDA
Marketing start
2025-07-01
Substance
LUBIPROSTONE
Active strength
.008 mg/1
Pharmacologic classes
Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lubiprostone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LUBIPROSTONE.008 mg/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
72603-288-01Lubiprostone60 in 1 BOTTLECAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-288-01EA - Each72603-288131281eb-cfc4-4ca5-a6a7-9ebb13a5942512025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616578lubiprostone 24 MCG Oral CapsulePSN1626ac65-ea12-421b-9780-bfdb50a39e1a1
794639lubiprostone 8 MCG Oral CapsulePSN1626ac65-ea12-421b-9780-bfdb50a39e1a1
794639lubiprostone 0.008 MG Oral CapsuleSCD1626ac65-ea12-421b-9780-bfdb50a39e1a1
616578lubiprostone 0.024 MG Oral CapsuleSCD1626ac65-ea12-421b-9780-bfdb50a39e1a1
616578lubiprostone 24 MCG Oral CapsuleSY1626ac65-ea12-421b-9780-bfdb50a39e1a1
794639lubiprostone 8 MCG Oral CapsuleSY1626ac65-ea12-421b-9780-bfdb50a39e1a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-288-017260302880160 CAPSULE in 1 BOTTLE (72603-288-01) 60 capsule2025-07-01NoNoHistorical