FDA.reportPublic FDA data

5 ML ziconotide acetate 0.1 MG/ML Injection

RxCUI
1738357
RxNorm name
5 ML ziconotide acetate 0.1 MG/ML Injection
Display name
5 ML ziconotide acetate 0.1 MG/ML Injection
Full name
5 ML ziconotide acetate 0.1 MG/ML Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:16

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
PRIALTZICONOTIDE ACETATEESTEVE PHARMACEUTICALS, S.A.57376a5b-4530-9018-e063-6394a90a9afe2026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1738357
PRIALTZICONOTIDE ACETATETerSera Therapeutics LLCb025d8ed-937d-4597-9ad1-0b2f6e0ee5b12025-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1738357

DailyMed RxNorm Mappings#

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

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
b025d8ed-937d-4597-9ad1-0b2f6e0ee5b1ziconotide 500 MCG in 5 ML Injection [PSN] · 5 ML ziconotide acetate 0.1 MG/ML Injection [SCD] · ziconotide 500 MCG per 5 ML Injection [SY]36These highlights do not include all the information needed to use PRIALT safely and effectively. See full prescribing information for PRIALT. PRIALT (ziconotide) solution, intrathecal infusion Initial U.S. Approval: 200420250531