FDA.reportPublic FDA data

Lubiprostone

Product NDC
71205-831
11-digit product format
712050831
Labeler code
71205
Product ID
71205-831_4aed57d0-99d8-424e-a1c7-0cd8a31a66cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lubiprostone
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
NDA021908
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2023-01-01
Substance
LUBIPROSTONE
Active strength
8 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LUBIPROSTONE8 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7662KG2R6K
Rxcui794639

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
71205-831-00Lubiprostone100 in 1 BOTTLECAPSULE, GELATIN COATED1001
71205-831-11Lubiprostone1000 in 1 BOTTLECAPSULE, GELATIN COATED10001
71205-831-30Lubiprostone30 in 1 BOTTLECAPSULE, GELATIN COATED301
71205-831-55Lubiprostone500 in 1 BOTTLECAPSULE, GELATIN COATED5001
71205-831-60Lubiprostone60 in 1 BOTTLECAPSULE, GELATIN COATED601
71205-831-64Lubiprostone240 in 1 BOTTLECAPSULE, GELATIN COATED2401
71205-831-67Lubiprostone270 in 1 BOTTLECAPSULE, GELATIN COATED2701
71205-831-72Lubiprostone120 in 1 BOTTLECAPSULE, GELATIN COATED1201
71205-831-78Lubiprostone180 in 1 BOTTLECAPSULE, GELATIN COATED1801
71205-831-90Lubiprostone90 in 1 BOTTLECAPSULE, GELATIN COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-831LUBIPROSTONE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1Current NDC, 10 package rows20231019_4aed57d0-99d8-424e-a1c7-0cd8a31a66cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
794639lubiprostone 8 MCG Oral CapsulePSN4aed57d0-99d8-424e-a1c7-0cd8a31a66cf1
794639lubiprostone 0.008 MG Oral CapsuleSCD4aed57d0-99d8-424e-a1c7-0cd8a31a66cf1
794639lubiprostone 8 MCG Oral CapsuleSY4aed57d0-99d8-424e-a1c7-0cd8a31a66cf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-831-0071205083100100 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-00) 2023-10-18NoNoHistorical
71205-831-11712050831111000 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-11) 2023-10-18NoNoHistorical
71205-831-307120508313030 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-30) 2023-10-18NoNoHistorical
71205-831-5571205083155500 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-55) 2023-10-18NoNoHistorical
71205-831-607120508316060 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-60) 2023-10-18NoNoHistorical
71205-831-6471205083164240 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-64) 2023-10-18NoNoHistorical
71205-831-6771205083167270 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-67) 2023-10-18NoNoHistorical
71205-831-7271205083172120 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-72) 2023-10-18NoNoHistorical
71205-831-7871205083178180 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-78) 2023-10-18NoNoHistorical
71205-831-907120508319090 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-90) 2023-10-18NoNoHistorical