FDA.reportPublic FDA data

Amitiza

Product NDC
64764-240
11-digit product format
647640240
Labeler code
64764
Product ID
64764-240_c2ca8178-4da1-42d1-a8b9-ff66dca82649
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lubiprostone
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Takeda Pharmaceuticals America, Inc.
Application
NDA021908
Marketing category
NDA
Marketing start
2006-01-31
Marketing end
2027-03-31
Substance
LUBIPROSTONE
Active strength
24 ug/1
Pharmacologic classes
Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amitiza

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LUBIPROSTONE24 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7662KG2R6K
Rxcui616578, 617768, 794639, 794641

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3b517f14-6449-952f-8aaf-98f2ec9051d0Product name320251024
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64764-240-10Amitiza100 in 1 BOTTLECAPSULE, GELATIN COATED10021
64764-240-40Amitiza1 in 1 CARTONCAPSULE, GELATIN COATED121
64764-240-40Amitiza4 in 1 CARTONCAPSULE, GELATIN COATED421
64764-240-60Amitiza60 in 1 BOTTLECAPSULE, GELATIN COATED6021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64764-240-60EA - Each64764-240af136514-bbef-44de-8079-0753642e560d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
lubiprostoneACTIVE INGREDIENT7662KG2R6KAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]10
lubiprostoneACTIVE MOIETY7662KG2R6KAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]10
D&C yellow no. 10INACTIVE INGREDIENT35SW5USQ3GAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]10
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOAAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]10
ferric oxide redINACTIVE INGREDIENT1K09F3G675AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]10
gelatinINACTIVE INGREDIENT2G86QN327LAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]10
medium-chain triglyceridesINACTIVE INGREDIENTC9H2L21V7UAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]10
sorbitolINACTIVE INGREDIENT506T60A25RAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]10
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]10
waterINACTIVE INGREDIENT059QF0KO0RAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]10
LUBIPROSTONEACTIVE INGREDIENT7662KG2R6KAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]3
LUBIPROSTONEACTIVE MOIETY7662KG2R6KAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]3
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]3
SORBITOLINACTIVE INGREDIENT506T60A25RAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]3
lubiprostoneACTIVE INGREDIENT7662KG2R6KAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]2
lubiprostoneACTIVE MOIETY7662KG2R6KAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]2
SORBITOLINACTIVE INGREDIENT506T60A25RAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]2
WATERINACTIVE INGREDIENT059QF0KO0RAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64764-240AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]21Current NDC, Legacy NDC, 4 package rows20240302_d474ac6a-444d-4aa6-9986-24be6fcf811d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617768Amitiza 24 MCG Oral CapsulePSNd474ac6a-444d-4aa6-9986-24be6fcf811d21
794641Amitiza 8 MCG Oral CapsulePSNd474ac6a-444d-4aa6-9986-24be6fcf811d21
616578lubiprostone 24 MCG Oral CapsulePSNd474ac6a-444d-4aa6-9986-24be6fcf811d21
794639lubiprostone 8 MCG Oral CapsulePSNd474ac6a-444d-4aa6-9986-24be6fcf811d21
794641lubiprostone 0.008 MG Oral Capsule [Amitiza]SBDd474ac6a-444d-4aa6-9986-24be6fcf811d21
617768lubiprostone 0.024 MG Oral Capsule [Amitiza]SBDd474ac6a-444d-4aa6-9986-24be6fcf811d21
794639lubiprostone 0.008 MG Oral CapsuleSCDd474ac6a-444d-4aa6-9986-24be6fcf811d21
616578lubiprostone 0.024 MG Oral CapsuleSCDd474ac6a-444d-4aa6-9986-24be6fcf811d21
794641Amitiza 0.008 MG Oral CapsuleSYd474ac6a-444d-4aa6-9986-24be6fcf811d21
617768Amitiza 0.024 MG Oral CapsuleSYd474ac6a-444d-4aa6-9986-24be6fcf811d21
617768Amitiza 24 MCG Oral CapsuleSYd474ac6a-444d-4aa6-9986-24be6fcf811d21
794641Amitiza 8 MCG Oral CapsuleSYd474ac6a-444d-4aa6-9986-24be6fcf811d21
616578lubiprostone 24 MCG Oral CapsuleSYd474ac6a-444d-4aa6-9986-24be6fcf811d21
794639lubiprostone 8 MCG Oral CapsuleSYd474ac6a-444d-4aa6-9986-24be6fcf811d21
617768Amitiza 24 MCG Oral CapsulePSN222817c2-d4a6-43d0-8cbb-215f19acb1983
794641Amitiza 8 MCG Oral CapsulePSN222817c2-d4a6-43d0-8cbb-215f19acb1983
616578lubiprostone 24 MCG Oral CapsulePSN222817c2-d4a6-43d0-8cbb-215f19acb1983
794639lubiprostone 8 MCG Oral CapsulePSN222817c2-d4a6-43d0-8cbb-215f19acb1983
794641lubiprostone 0.008 MG Oral Capsule [Amitiza]SBD222817c2-d4a6-43d0-8cbb-215f19acb1983
617768lubiprostone 0.024 MG Oral Capsule [Amitiza]SBD222817c2-d4a6-43d0-8cbb-215f19acb1983
794639lubiprostone 0.008 MG Oral CapsuleSCD222817c2-d4a6-43d0-8cbb-215f19acb1983
616578lubiprostone 0.024 MG Oral CapsuleSCD222817c2-d4a6-43d0-8cbb-215f19acb1983
794641Amitiza 0.008 MG Oral CapsuleSY222817c2-d4a6-43d0-8cbb-215f19acb1983
617768Amitiza 0.024 MG Oral CapsuleSY222817c2-d4a6-43d0-8cbb-215f19acb1983
617768Amitiza 24 MCG Oral CapsuleSY222817c2-d4a6-43d0-8cbb-215f19acb1983
794641Amitiza 8 MCG Oral CapsuleSY222817c2-d4a6-43d0-8cbb-215f19acb1983
616578lubiprostone 24 MCG Oral CapsuleSY222817c2-d4a6-43d0-8cbb-215f19acb1983
794639lubiprostone 8 MCG Oral CapsuleSY222817c2-d4a6-43d0-8cbb-215f19acb1983
617768Amitiza 24 MCG Oral CapsulePSN1b632d92-a05b-42d3-88a6-b3e345d11fe42
616578lubiprostone 24 MCG Oral CapsulePSN1b632d92-a05b-42d3-88a6-b3e345d11fe42
617768lubiprostone 0.024 MG Oral Capsule [Amitiza]SBD1b632d92-a05b-42d3-88a6-b3e345d11fe42
616578lubiprostone 0.024 MG Oral CapsuleSCD1b632d92-a05b-42d3-88a6-b3e345d11fe42
617768Amitiza 0.024 MG Oral CapsuleSY1b632d92-a05b-42d3-88a6-b3e345d11fe42
617768Amitiza 24 MCG Oral CapsuleSY1b632d92-a05b-42d3-88a6-b3e345d11fe42
616578lubiprostone 24 MCG Oral CapsuleSY1b632d92-a05b-42d3-88a6-b3e345d11fe42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64764-240-1064764024010100 CAPSULE, GELATIN COATED in 1 BOTTLE (64764-240-10) 2006-01-310000-00-00NoNoCurrent
64764-240-40647640240404 CARTON in 1 CARTON (64764-240-40) > 1 BLISTER PACK in 1 CARTON > 4 CAPSULE, GELATIN COATED in 1 BLISTER PACK4 carton2006-01-310000-00-00NoNoCurrent
64764-240-606476402406060 CAPSULE, GELATIN COATED in 1 BOTTLE (64764-240-60) 2006-01-312027-03-31NoNoCurrent