FDA.reportPublic FDA data

Amitiza

Product NDC
64764-080
11-digit product format
647640080
Labeler code
64764
Product ID
64764-080_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
8 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
LUBIPROSTONE8 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64764-080-40Amitiza1 in 1 CARTONCAPSULE, GELATIN COATED121
64764-080-40Amitiza4 in 1 CARTONCAPSULE, GELATIN COATED421
64764-080-60Amitiza60 in 1 BOTTLECAPSULE, GELATIN COATED6021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64764-080-60EA - Each64764-0808e2d69c6-29a9-4d62-b497-22673261c7a112012-07-24

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 [STAT RX USA LLC]1
LUBIPROSTONEACTIVE MOIETY7662KG2R6KAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [STAT RX USA LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [STAT RX USA LLC]1
GELATININACTIVE INGREDIENT2G86QN327LAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [STAT RX USA LLC]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [STAT RX USA LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [STAT RX USA LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RAMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64764-080AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]21Current NDC, Legacy NDC, 3 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
794641Amitiza 8 MCG Oral CapsulePSNca79dddc-3911-472b-bda7-a23351be09af1
794639lubiprostone 8 MCG Oral CapsulePSNca79dddc-3911-472b-bda7-a23351be09af1
794641lubiprostone 0.008 MG Oral Capsule [Amitiza]SBDca79dddc-3911-472b-bda7-a23351be09af1
794639lubiprostone 0.008 MG Oral CapsuleSCDca79dddc-3911-472b-bda7-a23351be09af1
794641Amitiza 0.008 MG Oral CapsuleSYca79dddc-3911-472b-bda7-a23351be09af1
794641Amitiza 8 MCG Oral CapsuleSYca79dddc-3911-472b-bda7-a23351be09af1
794639lubiprostone 8 MCG Oral CapsuleSYca79dddc-3911-472b-bda7-a23351be09af1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64764-080-40647640080404 CARTON in 1 CARTON (64764-080-40) > 1 BLISTER PACK in 1 CARTON > 4 CAPSULE, GELATIN COATED in 1 BLISTER PACK4 carton2008-04-290000-00-00NoNoCurrent
64764-080-606476400806060 CAPSULE, GELATIN COATED in 1 BOTTLE (64764-080-60) 2006-01-310000-00-00NoNoCurrent