Palonosetron (palonosetron hydrochloride) NDC 60505-6193

NDC codes

FDA NDC Directory

Product NDC (as listed)60505-6193Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60505-6193Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
60505-6193-1	60505619301	1 VIAL in 1 CARTON (60505-6193-1) / 5 mL in 1 VIALMarketed from Sep 19, 2018
60505-6193-4	60505619304	10 VIAL in 1 CARTON (60505-6193-4) / 5 mL in 1 VIALMarketed from Sep 19, 2018

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Generic name (nonproprietary): palonosetron hydrochloride
Active ingredients: Palonosetron hydrochloride — .25 mg/5mL
Dosage form: Injection
Route: Intravenous
Labeler: Apotex Corp.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205648
Marketing start: Sep 19, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers: Product ID 60505-6193_74b0b374-522d-4194-8646-1acb37e23c5fSPL ID 74b0b374-522d-4194-8646-1acb37e23c5fSPL set ID 903d7aba-277e-6d28-4fee-fd2d605ab6a9RxCUI 1728055UNII 23310D4I19UPC 0360505619313
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.

How CPT relates to drug billing

NDC on a medical claim

N460505619301 followed by a unit qualifier and the quantity

Package 60505-6193-01. 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 Jan 2, 2025.

Indications (excerpt from the label)

Palonosetron Hydrochloride Injection is a serotonin-3 (5-HT 3 ) receptor antagonist indicated in: Adults for prevention of : acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). ( 1 ) acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC). ( 1 ) postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated ( 1 ) Pediatric patients aged 1 month to less than 17 years for prevention of : acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy,…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205648

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 205648
Product	Strength	Form · route	Labeler	Product NDC
Palonosetronpalonosetron hydrochloride	Palonosetron hydrochloride .25 mg/5mL	InjectionIntravenous	Apotex Corp.	60505-6439
Palonosetronpalonosetron hydrochloride	Palonosetron hydrochloride .25 mg/5mL	InjectionIntravenous	BLuePoint Laboratories	68001-708
Palonosetronpalonosetron hydrochloride	Palonosetron hydrochloride .25 mg/5mL	InjectionIntravenous	Qilu Pharmaceutical Co., Ltd.	67184-0514
Palonosetronpalonosetron hydrochloride	Palonosetron hydrochloride .075 mg/1.5mL	InjectionIntravenous	Qilu Pharmaceutical Co., Ltd.	67184-0515