FDA.reportPublic FDA data

Lubiprostone

Product NDC
71205-832
11-digit product format
712050832
Labeler code
71205
Product ID
71205-832_ea61ffd1-0610-4264-b964-00a9f4485d36
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
71205-832-00Lubiprostone100 in 1 BOTTLECAPSULE, GELATIN COATED1001
71205-832-11Lubiprostone1000 in 1 BOTTLECAPSULE, GELATIN COATED10001
71205-832-30Lubiprostone30 in 1 BOTTLECAPSULE, GELATIN COATED301
71205-832-55Lubiprostone500 in 1 BOTTLECAPSULE, GELATIN COATED5001
71205-832-60Lubiprostone60 in 1 BOTTLECAPSULE, GELATIN COATED601
71205-832-64Lubiprostone240 in 1 BOTTLECAPSULE, GELATIN COATED2401
71205-832-67Lubiprostone270 in 1 BOTTLECAPSULE, GELATIN COATED2701
71205-832-72Lubiprostone120 in 1 BOTTLECAPSULE, GELATIN COATED1201
71205-832-78Lubiprostone180 in 1 BOTTLECAPSULE, GELATIN COATED1801
71205-832-90Lubiprostone90 in 1 BOTTLECAPSULE, GELATIN COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-832-00EA - Each71205-832eac034c2-51b3-47af-8fae-4923355fcf3a12023-09-05
71205-832-11EA - Each71205-8322f411c63-95cb-401f-842e-5d963e74ddd412023-09-05
71205-832-30EA - Each71205-832eb15ec60-28a9-4919-9a21-95899048a13b12023-09-05
71205-832-55EA - Each71205-832d168ca27-02e0-4d65-a40e-a8c80f9c409e12023-09-05
71205-832-60EA - Each71205-83244c8c732-1fa6-4121-98db-bb15f626472c12023-09-05
71205-832-64EA - Each71205-832376bc324-dee6-490d-834c-f863c5365b7112023-09-05
71205-832-67EA - Each71205-8328916e1e0-7b85-4aae-9917-92ff480ecb4012023-09-05
71205-832-72EA - Each71205-832f2d3aed4-d2c6-4726-a4fc-483ad840a31612023-09-05
71205-832-78EA - Each71205-832b81a681e-b81f-4683-8701-fa58e21382fe12023-09-05
71205-832-90EA - Each71205-832bf0591e9-adc4-43c4-91c0-bb47d03bab0f12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-832LUBIPROSTONE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1Current NDC, 10 package rows20230819_ea61ffd1-0610-4264-b964-00a9f4485d36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616578lubiprostone 24 MCG Oral CapsulePSNea61ffd1-0610-4264-b964-00a9f4485d361
616578lubiprostone 0.024 MG Oral CapsuleSCDea61ffd1-0610-4264-b964-00a9f4485d361
616578lubiprostone 24 MCG Oral CapsuleSYea61ffd1-0610-4264-b964-00a9f4485d361

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-832-0071205083200100 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-00) 2023-08-18NoNoCurrent
71205-832-11712050832111000 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-11) 2023-08-18NoNoCurrent
71205-832-307120508323030 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-30) 2023-08-18NoNoCurrent
71205-832-5571205083255500 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-55) 2023-08-18NoNoCurrent
71205-832-607120508326060 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-60) 2023-08-18NoNoCurrent
71205-832-6471205083264240 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-64) 2023-08-18NoNoCurrent
71205-832-6771205083267270 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-67) 2023-08-18NoNoCurrent
71205-832-7271205083272120 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-72) 2023-08-18NoNoCurrent
71205-832-7871205083278180 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-78) 2023-08-18NoNoCurrent
71205-832-907120508329090 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-90) 2023-08-18NoNoCurrent