Lubiprostone

Product NDC
71205-834
11-digit product format
712050834
Labeler code
71205
Product ID
71205-834_a368117c-0e80-4dbc-a0a7-9b88dbfeece3
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
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LUBIPROSTONE24 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7662KG2R6K
Rxcui616578

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
71205-834-00Lubiprostone100 in 1 BOTTLECAPSULE, GELATIN COATED1001
71205-834-11Lubiprostone1000 in 1 BOTTLECAPSULE, GELATIN COATED10001
71205-834-30Lubiprostone30 in 1 BOTTLECAPSULE, GELATIN COATED301
71205-834-55Lubiprostone500 in 1 BOTTLECAPSULE, GELATIN COATED5001
71205-834-60Lubiprostone60 in 1 BOTTLECAPSULE, GELATIN COATED601
71205-834-64Lubiprostone240 in 1 BOTTLECAPSULE, GELATIN COATED2401
71205-834-67Lubiprostone270 in 1 BOTTLECAPSULE, GELATIN COATED2701
71205-834-72Lubiprostone120 in 1 BOTTLECAPSULE, GELATIN COATED1201
71205-834-78Lubiprostone180 in 1 BOTTLECAPSULE, GELATIN COATED1801
71205-834-90Lubiprostone90 in 1 BOTTLECAPSULE, GELATIN COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-834-00EA - Each71205-8340f0763ca-be2f-48e1-9a3f-b10e5baac47912023-09-05
71205-834-11EA - Each71205-834aaaf0c30-9c19-4e41-8d9d-088ebc81486312023-09-05
71205-834-30EA - Each71205-834dccb4d10-faf8-4883-ac59-8a9d207e2a2f12023-09-05
71205-834-55EA - Each71205-834d74f8337-989e-48a6-9ed2-85e9a73ddd4c12023-09-05
71205-834-60EA - Each71205-834b4cdb378-03ca-41f7-9124-470b9a86e5fa12023-09-05
71205-834-64EA - Each71205-834e392e80b-b8e8-4440-bc75-957b8b84096212023-09-05
71205-834-67EA - Each71205-83460260bcc-90bb-4dae-ab22-5010ae8d537712023-09-05
71205-834-72EA - Each71205-8341175b461-f20c-44ea-b191-75f5f640bddf12023-09-05
71205-834-78EA - Each71205-8348c67dee0-ad9c-4a91-8a89-ceeb780ce40a12023-09-05
71205-834-90EA - Each71205-8347af563c3-a24c-4a2f-ad3e-1d60bac4aa8412023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-834LUBIPROSTONE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1Current NDC, 10 package rows20230819_a368117c-0e80-4dbc-a0a7-9b88dbfeece3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616578lubiprostone 24 MCG Oral CapsulePSNa368117c-0e80-4dbc-a0a7-9b88dbfeece31
616578lubiprostone 0.024 MG Oral CapsuleSCDa368117c-0e80-4dbc-a0a7-9b88dbfeece31
616578lubiprostone 24 MCG Oral CapsuleSYa368117c-0e80-4dbc-a0a7-9b88dbfeece31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-834-0071205083400100 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-00) 2023-08-18NoNoCurrent
71205-834-11712050834111000 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-11) 2023-08-18NoNoCurrent
71205-834-307120508343030 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-30) 2023-08-18NoNoCurrent
71205-834-5571205083455500 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-55) 2023-08-18NoNoCurrent
71205-834-607120508346060 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-60) 2023-08-18NoNoCurrent
71205-834-6471205083464240 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-64) 2023-08-18NoNoCurrent
71205-834-6771205083467270 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-67) 2023-08-18NoNoCurrent
71205-834-7271205083472120 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-72) 2023-08-18NoNoCurrent
71205-834-7871205083478180 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-78) 2023-08-18NoNoCurrent
71205-834-907120508349090 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-90) 2023-08-18NoNoCurrent