What is NDC 63323-673?

63323-673 is the product NDC for Palonosetron, Palonosetron hydrochloride .25 mg/5mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Palonosetron?

8 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Palonosetron NDC 63323-673 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-673Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0673Add 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
63323-673-89	6332306738963323067389	10 SYRINGE, PLASTIC in 1 CARTON (63323-673-89) / 5 mL in 1 SYRINGE, PLASTIC (63323-673-21)Marketed from Sep 19, 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 — .25 mg/5mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Fresenius Kabi USA, LLCNDC labeler code 63323
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206801
Marketing start: Sep 19, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers: Product ID 63323-673_c1aa6a23-e1b5-441a-a947-55b35d33509bSPL ID c1aa6a23-e1b5-441a-a947-55b35d33509bSPL set ID b93fae8e-2b76-421e-95bc-ba08c211a7eaRxCUI 2056929UNII 23310D4I19UPC 0363323673215
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

N463323067389 followed by a unit qualifier and the quantity

Package 63323-0673-89. 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 11, 2021.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE 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). Palonosetron Hydrochloride Injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of: acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy. Palonosetron Hydrochloride Injection is a serotonin-3 (5-HT 3 ) rece…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63323-673

What is NDC 63323-673?: 63323-673 is the product NDC for Palonosetron, Palonosetron hydrochloride .25 mg/5mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Palonosetron.
What is the active ingredient?: Palonosetron hydrochloride.
Who is the labeler?: Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Palonosetron?: 8 other product NDCs are listed under this name. See all Palonosetron NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Palonosetron NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Palonosetronpalonosetron hydrochloride	Palonosetron hydrochloride .25 mg/5mL	InjectionIntravenous	BLuePoint Laboratories	68001-708	68001-0708-25
Palonosetronpalonosetron hydrochloride	Palonosetron hydrochloride .25 mg/5mL	InjectionIntravenous	Apotex Corp.	60505-6439	60505-6439-01
Palonosetronpalonosetron hydrochloride	Palonosetron hydrochloride .25 mg/5mL	InjectionIntravenous	Apotex Corp.	60505-6193	60505-6193-0160505-6193-04
Palonosetronpalonosetron hydrochloride	Palonosetron hydrochloride .25 mg/5mL	InjectionIntravenous	Qilu Pharmaceutical Co., Ltd.	67184-0514	67184-0514-01
Palonosetronpalonosetron hydrochloride	Palonosetron hydrochloride .075 mg/1.5mL	InjectionIntravenous	Qilu Pharmaceutical Co., Ltd.	67184-0515	67184-0515-02
Palonosetron	Palonosetron hydrochloride .05 mg/mL	Injection, SolutionIntravenous	BluePoint Laboratories	68001-355	68001-0355-25
Palonosetron	Palonosetron hydrochloride .05 mg/mL	Injection, SolutionIntravenous	NorthStar Rx LLC	16714-834	16714-0834-01
Palonosetron	Palonosetron hydrochloride .05 mg/mL	Injection, SolutionIntravenous	Dr.Reddy's Laboratories Limited	55111-694	55111-0694-0755111-0694-19