Prescription drug · NDA
Prialt (Ziconotide acetate) NDC 70720-722
Ziconotide acetate 100 ug/mL · Injection, Solution · Intrathecal · TerSera Therapeutics LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70720-722-10 | 70720072210 | 1 VIAL, GLASS in 1 CARTON (70720-722-10) / 5 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
- TerSera Therapeutics LLCNDC labeler code 70720
- 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 70720-722_a7101558-afb8-443b-8c26-a238e26bb40cSPL ID a7101558-afb8-443b-8c26-a238e26bb40cSPL set ID b025d8ed-937d-4597-9ad1-0b2f6e0ee5b1RxCUI 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
N470720072210followed by a unit qualifier and the quantityPackage 70720-0722-10. 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.
About NDC 70720-722
- What is NDC 70720-722?
- 70720-722 is the product NDC for Prialt (ziconotide acetate), Ziconotide acetate 100 ug/mL injection, solution, listed with the FDA by TerSera Therapeutics LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Prialt (Ziconotide acetate).
- What is the active ingredient?
- Ziconotide acetate.
- Who is the labeler?
- TerSera Therapeutics LLC, NDC labeler code 70720. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Prialt?
- 5 other product NDCs are listed under this name. See all Prialt NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Prialt products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Prialtziconotide acetate | Ziconotide acetate 100 ug/mL | Injection, SolutionIntrathecal | ESTEVE PHARMACEUTICALS, S.A. | 68118-720 | 68118-0720-10 |
| Prialtziconotide acetate | Ziconotide acetate 500 ug/5mL | Injection, SolutionIntrathecal | ESTEVE PHARMACEUTICALS, S.A. | 68118-722 | 68118-0722-10 |
| Prialtziconotide acetate | Ziconotide acetate 500 ug/20mL | Injection, SolutionIntrathecal | ESTEVE PHARMACEUTICALS, S.A. | 68118-723 | 68118-0723-10 |
| Prialtziconotide acetate | Ziconotide acetate 100 ug/mL | Injection, SolutionIntrathecal | TerSera Therapeutics LLC | 70720-720 | 70720-0720-10 |
| Prialtziconotide acetate | Ziconotide acetate 25 ug/mL | Injection, SolutionIntrathecal | TerSera Therapeutics LLC | 70720-723 | 70720-0723-10 |
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 100 ug/mL | Injection, SolutionIntrathecal | ESTEVE PHARMACEUTICALS, S.A. | 68118-720 |
| 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 100 ug/mL | Injection, SolutionIntrathecal | TerSera Therapeutics LLC | 70720-720 |
| Prialtziconotide acetate | Ziconotide acetate 25 ug/mL | Injection, SolutionIntrathecal | TerSera Therapeutics LLC | 70720-723 |