Palonosetron NDC 68001-355

NDC codes

FDA NDC Directory

Product NDC (as listed)68001-355Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68001-0355Add 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
68001-355-25	68001035525	1 VIAL, SINGLE-USE in 1 CARTON (68001-355-25) / 5 mL in 1 VIAL, SINGLE-USEMarketed from May 30, 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
Generic name (nonproprietary): palonosetron
Active ingredients: Palonosetron hydrochloride — .05 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: BluePoint Laboratories
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201533
Marketing start: May 30, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers: Product ID 68001-355_59e26e01-70a8-ce59-e063-6294a90a45c8SPL ID 59e26e01-70a8-ce59-e063-6294a90a45c8SPL set ID ee6f6f94-1ca7-481e-9909-b19ae64e80c2RxCUI 1728055UNII 23310D4I19UPC 0368001355254
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

N468001035525 followed by a unit qualifier and the quantity

Package 68001-0355-25. 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 Aug 25, 2026.

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 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 postoper…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 201533

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

FDA NDC Directory listings under ANDA 201533
Product	Strength	Form · route	Labeler	Product NDC
Palonosetron	Palonosetron hydrochloride .05 mg/mL	Injection, SolutionIntravenous	NorthStar Rx LLC	16714-834
Palonosetron	Palonosetron hydrochloride .05 mg/mL	Injection, SolutionIntravenous	Dr.Reddy's Laboratories Limited	55111-694