Prescription drug · NDA AUTHORIZED GENERIC
palonosetron hydrochloride NDC 69097-927
Palonosetron hydrochloride .25 mg/5mL · Injection · Intravenous · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-927-35 | 69097092735 | 1 VIAL in 1 CARTON (69097-927-35) / 5 mL in 1 VIALMarketed from Mar 23, 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
- Route
- Intravenous
- Labeler
- Cipla USA Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021372
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 69097-927_04460041-adec-463b-ba9d-6a12038ab672SPL ID 04460041-adec-463b-ba9d-6a12038ab672SPL set ID 37e7ef89-fd77-44e0-9271-ae91f8822603RxCUI 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
N469097092735followed by a unit qualifier and the quantityPackage 69097-0927-35. 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 a serotonin-3 (5-HT 3 ) receptor antagonist indicated in adults for: Moderately emetogenic cancer chemotherapy - prevention of acute and delayed nausea and vomiting associated with initial and repeat courses ( 1 .1) Highly emetogenic cancer chemotherapy - prevention of acute nausea and vomiting associated with initial and repeat courses ( 1.1 ) Prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated ( 1.3 ) Palonosetron Hydrochloride Injection is indicated in pediatric patients aged 1 month to less than 17 years for: Prevention of acute nausea and vomiting associate…
Excerpt only. Read the full label for complete information.