Prescription drug · ANDA
Palonosetron Hydrochloride NDC 67457-317
Palonosetron hydrochloride .25 mg/5mL · Injection, Solution · Intravenous · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67457-317-25 | 67457031725 | 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-317-25) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 20, 2018 |
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)
- Palonosetron Hydrochloride
- Generic name (nonproprietary)
- palonosetron hydrochloride
- Active ingredients
- Palonosetron hydrochloride — .25 mg/5mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Mylan Institutional LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206416
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 67457-317_4fbe587d-ddb7-42fd-aad9-e749689d2276SPL ID 4fbe587d-ddb7-42fd-aad9-e749689d2276SPL set ID 0a781796-bb74-4c5f-8d26-9ce520b818f7RxCUI 1728055UNII 23310D4I19
- Pharmacologic class
- Serotonin-3 Receptor 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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N467457031725followed by a unit qualifier and the quantityPackage 67457-0317-25. 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 .
Indications (excerpt from the label)
Palonosetron hydrochloride injection is indicated in adults for prevention of: • acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). • acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC). • postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated. As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and vomiting must be avoided during the…
Excerpt only. Read the full label for complete information.