Lubiprostone

Product NDC
76420-907
11-digit product format
764200907
Labeler code
76420
Product ID
76420-907_2cbe759e-e896-7ada-e063-6394a90a6cc5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lubiprostone
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
NDA021908
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2023-01-01
Substance
LUBIPROSTONE
Active strength
24 ug/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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
7662KG2R6KLUBIPROSTONE136790-76-6LUBIPROSTONE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76420-907-0176420090701100 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-907-01) 2025-01-28NoNoHistorical
76420-907-307642009073030 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-907-30) 2025-01-28NoNoHistorical
76420-907-607642009076060 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-907-60) 2025-01-28NoNoHistorical
76420-907-907642009079090 CAPSULE, GELATIN COATED in 1 BOTTLE (76420-907-90) 2025-01-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
LubiprostoneAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2025-01-28HUMAN PRESCRIPTION DRUG LABEL1