Lubiprostone

Product NDC
55700-963
11-digit product format
557000963
Labeler code
55700
Product ID
55700-963_0f363535-8849-4b9c-ae01-4b50a696500c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lubiprostone
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Quality Care Products, LLC
Application
NDA021908
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2022-02-17
Marketing end
2026-05-31
Substance
LUBIPROSTONE
Active strength
24 ug/1
Pharmacologic classes
Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]
NDC exclude flag
No
Current FDA listing
Yes

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
55700-963-60Lubiprostone60 in 1 BOTTLECAPSULE, GELATIN COATED603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-963LUBIPROSTONE CAPSULE, GELATIN COATED [QUALITY CARE PRODUCTS, LLC]3Current NDC, Legacy NDC, 1 package rows20241222_b21d1f2d-9890-48fc-acdc-9c8c4fe55a34.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-963-605570009636060 CAPSULE, GELATIN COATED in 1 BOTTLE (55700-963-60) 2022-02-172026-05-31NoNoCurrent