Prescription drug · NDA
Prialt (ziconotide acetate) NDC 68118-720
Ziconotide acetate 100 ug/mL · Injection, Solution · Intrathecal · ESTEVE PHARMACEUTICALS, S.A.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68118-720-10 | 68118072010 | 1 VIAL, GLASS in 1 CARTON (68118-720-10) / 1 mL in 1 VIAL, GLASSMarketed from Aug 15, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Prialt
- Generic name (nonproprietary)
- ziconotide acetate
- Active ingredients
- Ziconotide acetate — 100 ug/mL
- Dosage form
- Injection, Solution
- Route
- Intrathecal
- Labeler
- ESTEVE PHARMACEUTICALS, S.A.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021060
- Marketing start
- Listing expires
- Other FDA classes
- N-Calcium Channel Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 68118-720_57e9b601-e657-b5ef-e063-6394a90af39fSPL ID 57e9b601-e657-b5ef-e063-6394a90af39fSPL set ID 57376a5b-4530-9018-e063-6394a90a9afeRxCUI 486133, 583453, 1738353, 1738354, 1738357, 1738358UNII T2I226K69M
- Pharmacologic class
- N-type Calcium Channel Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N468118072010followed by a unit qualifier and the quantityPackage 68118-0720-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
PRIALT (ziconotide) solution, intrathecal infusion is indicated for the management of severe chronic pain in adult patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine. PRIALT (ziconotide) solution, intrathecal infusion is an N-type calcium channel antagonist indicated for the management of severe chronic pain in patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021060
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Prialtziconotide acetate | Ziconotide acetate 500 ug/5mL | Injection, SolutionIntrathecal | ESTEVE PHARMACEUTICALS, S.A. | 68118-722 |
| Prialtziconotide acetate | Ziconotide acetate 500 ug/20mL | Injection, SolutionIntrathecal | ESTEVE PHARMACEUTICALS, S.A. | 68118-723 |
| Prialtziconotide acetate | Ziconotide acetate 25 ug/mL | Injection, SolutionIntrathecal | TerSera Therapeutics LLC | 70720-723 |
| Prialtziconotide acetate | Ziconotide acetate 100 ug/mL | Injection, SolutionIntrathecal | TerSera Therapeutics LLC | 70720-720 |
| Prialtziconotide acetate | Ziconotide acetate 100 ug/mL | Injection, SolutionIntrathecal | TerSera Therapeutics LLC | 70720-722 |