FDA.reportPublic FDA data

Lubiprostone

Product NDC
82804-001
11-digit product format
828040001
Labeler code
82804
Product ID
82804-001_34c547c4-4c29-45a9-97c7-a828bf2ecde0
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
82804-001-30Lubiprostone30 in 1 BOTTLECAPSULE, GELATIN COATED301
82804-001-60Lubiprostone60 in 1 BOTTLECAPSULE, GELATIN COATED601
82804-001-90Lubiprostone90 in 1 BOTTLECAPSULE, GELATIN COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-001-60EA - Each82804-00173f4cf97-35e2-4a47-a358-42d41b1cfe9d12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-001LUBIPROSTONE CAPSULE, GELATIN COATED [PROFICIENT RX LP]1Current NDC, 3 package rows20230825_34c547c4-4c29-45a9-97c7-a828bf2ecde0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616578lubiprostone 24 MCG Oral CapsulePSN34c547c4-4c29-45a9-97c7-a828bf2ecde01
616578lubiprostone 0.024 MG Oral CapsuleSCD34c547c4-4c29-45a9-97c7-a828bf2ecde01
616578lubiprostone 24 MCG Oral CapsuleSY34c547c4-4c29-45a9-97c7-a828bf2ecde01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-001-308280400013030 CAPSULE, GELATIN COATED in 1 BOTTLE (82804-001-30) 2023-08-24NoNoCurrent
82804-001-608280400016060 CAPSULE, GELATIN COATED in 1 BOTTLE (82804-001-60) 2023-08-24NoNoCurrent
82804-001-908280400019090 CAPSULE, GELATIN COATED in 1 BOTTLE (82804-001-90) 2023-08-24NoNoCurrent