FDA.reportPublic FDA data

lubiprostone 0.008 MG Oral Capsule [Amitiza]

RxCUI
794641
RxNorm name
lubiprostone 0.008 MG Oral Capsule [Amitiza]
Display name
lubiprostone 0.008 MG Oral Capsule [Amitiza]
Full name
lubiprostone 0.008 MG Oral Capsule [Amitiza]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:22

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmitizaLUBIPROSTONESpecGx LLC164a2b47-0a52-4bb4-9e71-5342c2e951f42026-07-10Warnings, Adverse reactionsExact identifier
rxcui: 794641
AmitizaLUBIPROSTONETakeda Pharmaceuticals America, Inc.d474ac6a-444d-4aa6-9986-24be6fcf811d2024-01-18Warnings, Adverse reactionsExact identifier
rxcui: 794641

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 4 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
d474ac6a-444d-4aa6-9986-24be6fcf811dAmitiza 8 MCG Oral Capsule [PSN] · lubiprostone 0.008 MG Oral Capsule [Amitiza] [SBD] · Amitiza 0.008 MG Oral Capsule [SY] · Amitiza 8 MCG Oral Capsule [SY]421These 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: 200620240118
164a2b47-0a52-4bb4-9e71-5342c2e951f4Amitiza 8 MCG Oral Capsule [PSN] · lubiprostone 0.008 MG Oral Capsule [Amitiza] [SBD] · Amitiza 0.008 MG Oral Capsule [SY] · Amitiza 8 MCG Oral Capsule [SY]43These 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: 200620250911
222817c2-d4a6-43d0-8cbb-215f19acb198Amitiza 8 MCG Oral Capsule [PSN] · lubiprostone 0.008 MG Oral Capsule [Amitiza] [SBD] · Amitiza 0.008 MG Oral Capsule [SY] · Amitiza 8 MCG Oral Capsule [SY]43These highlights do not include all the information needed to use AMITIZA safely and effectively. See full prescribing information for AMITIZA. AMITIZA (lubiprostone) capsule, gelatin coated for oral use Initial U.S. Approval: 200620100518
ca79dddc-3911-472b-bda7-a23351be09afAmitiza 8 MCG Oral Capsule [PSN] · lubiprostone 0.008 MG Oral Capsule [Amitiza] [SBD] · Amitiza 0.008 MG Oral Capsule [SY] · Amitiza 8 MCG Oral Capsule [SY]41These highlights do not include all the information needed to use AMITIZA safely and effectively. See full prescribing information for AMITIZA. AMITIZA (lubiprostone) capsule, gelatin coated for oral use Initial U.S. Approval: 200620100721