FDA.reportPublic FDA data

Lubiprostone

Product NDC
70710-1642
11-digit product format
707101642
Labeler code
70710
Product ID
70710-1642_f06e99fa-9894-48ab-99d8-914987dbb73f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lubiprostone
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA214131
Marketing category
ANDA
Marketing start
2023-03-23
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, 794639

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
70710-1642-1Lubiprostone100 in 1 BOTTLECAPSULE1001
70710-1642-6Lubiprostone60 in 1 BOTTLECAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1642-6EA - Each70710-1642b5def7e9-c69a-4c65-91cc-591dfcf0993812023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1642LUBIPROSTONE CAPSULE [ZYDUS PHARMACEUTICALS USA INC.]1Current NDC, 2 package rows20230328_6c11a204-6831-4269-a3c4-1702ed83f74b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616578lubiprostone 24 MCG Oral CapsulePSN5797e57c-4e87-48d9-b16d-992f64db594f1
616578lubiprostone 24 MCG Oral CapsulePSN6c11a204-6831-4269-a3c4-1702ed83f74b1
794639lubiprostone 8 MCG Oral CapsulePSN5797e57c-4e87-48d9-b16d-992f64db594f1
794639lubiprostone 8 MCG Oral CapsulePSN6c11a204-6831-4269-a3c4-1702ed83f74b1
794639lubiprostone 0.008 MG Oral CapsuleSCD5797e57c-4e87-48d9-b16d-992f64db594f1
794639lubiprostone 0.008 MG Oral CapsuleSCD6c11a204-6831-4269-a3c4-1702ed83f74b1
616578lubiprostone 0.024 MG Oral CapsuleSCD5797e57c-4e87-48d9-b16d-992f64db594f1
616578lubiprostone 0.024 MG Oral CapsuleSCD6c11a204-6831-4269-a3c4-1702ed83f74b1
616578lubiprostone 24 MCG Oral CapsuleSY5797e57c-4e87-48d9-b16d-992f64db594f1
616578lubiprostone 24 MCG Oral CapsuleSY6c11a204-6831-4269-a3c4-1702ed83f74b1
794639lubiprostone 8 MCG Oral CapsuleSY5797e57c-4e87-48d9-b16d-992f64db594f1
794639lubiprostone 8 MCG Oral CapsuleSY6c11a204-6831-4269-a3c4-1702ed83f74b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70710-1642-170710164201100 CAPSULE in 1 BOTTLE (70710-1642-1) 100 capsule2023-03-23NoNoCurrent
70710-1642-67071016420660 CAPSULE in 1 BOTTLE (70710-1642-6) 60 capsule2023-03-23NoNoCurrent