Active ingredient
Ziconotide
6 finished FDA listings contain Ziconotide as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ZICONOTIDE, ZICONOTIDE ACETATE
- Dosage forms
- Injection, Solution
- Routes
- Intrathecal
- Manufacturers / labelers
- 2
- Strengths listed
- 100 ug/ml · 25 ug/ml · 500 ug/20ml · 500 ug/5ml
- Brand names in FDA listings
- Prialt
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 68503
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021060 | ESTEVE | 2004-12-28 | 6 |
Official labeling on DailyMed
- PRIALT (ZICONOTIDE ACETATE) INJECTION, SOLUTION [ESTEVE PHARMACEUTICALS, S.A.] · version 3 · 2026-08-03
- PRIALT (ZICONOTIDE ACETATE) INJECTION, SOLUTION [TERSERA THERAPEUTICS LLC] · version 6 · 2025-07-14
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.