FDA.reportPublic FDA data

Amitiza

Product NDC
68151-5003
11-digit product format
681515003
Labeler code
68151
Product ID
68151-5003_fa77ef52-a1a1-485e-96d4-cf2ff432a991
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lubiprostone
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Carilion Materials Management
Application
NDA021908
Marketing category
NDA
Marketing start
2006-01-31
Marketing end
0000-00-00
Substance
LUBIPROSTONE
Active strength
24 ug/1
Pharmacologic classes
Chloride Channel Activator [EPC],Chloride Channel Activators [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-5003-62020-01-31C16284748780-19d75b9d0-f856-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMITIZA safely and effectively. See full prescribing information for AMITIZA. AMITIZA (lubiprostone) capsules, for oral use Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-5003-6Amitiza1 in 1 PACKAGECAPSULE, GELATIN COATED12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
68151-5003AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20140820_1b632d92-a05b-42d3-88a6-b3e345d11fe4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionStatus
68151-5003-6681515003061 in 1 PACKAGEHistorical