What is NDC 67457-317?

67457-317 is the product NDC for Palonosetron Hydrochloride, Palonosetron hydrochloride .25 mg/5mL injection, solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Institutional LLC, NDC labeler code 67457. 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 Hydrochloride?

7 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Palonosetron Hydrochloride NDC 67457-317

NDC codes

FDA NDC Directory

Product NDC (as listed)67457-317Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67457-0317Add 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
67457-317-25	6745703172567457031725	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 LLCNDC labeler code 67457
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206416
Marketing start: Sep 20, 2018
Listing expires: Dec 31, 2027
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.

How CPT relates to drug billing

NDC on a medical claim

N467457031725 followed by a unit qualifier and the quantity

Package 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 Jun 9, 2020.

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.

Full label on DailyMed (opens in a new tab)

About NDC 67457-317

What is NDC 67457-317?: 67457-317 is the product NDC for Palonosetron Hydrochloride, Palonosetron hydrochloride .25 mg/5mL injection, solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Palonosetron Hydrochloride.
What is the active ingredient?: Palonosetron hydrochloride.
Who is the labeler?: Mylan Institutional LLC, NDC labeler code 67457. 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 Hydrochloride?: 7 other product NDCs are listed under this name. See all Palonosetron Hydrochloride 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 Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Palonosetron Hydrochloride	Palonosetron hydrochloride .25 mg/5mL	Injection, SolutionIntravenous	Meitheal Pharmaceuticals Inc.	71288-409	71288-0409-05
Palonosetron Hydrochloride	Palonosetron hydrochloride .25 mg/5mL	InjectionIntravenous	Baxter Healthcare Corporation	36000-326	36000-0326-02
Palonosetron Hydrochloride	Palonosetron hydrochloride .25 mg/5mL	Injection, SolutionIntravenous	Eugia US LLC	55150-186	55150-0186-05
palonosetron hydrochloride	Palonosetron hydrochloride .05 mg/mL	Injection, SolutionIntravenous	Sagent Pharmaceuticals	25021-783	25021-0783-05
Palonosetron Hydrochloride	Palonosetron hydrochloride .25 mg/5mL	Injection, SolutionIntravenous	Teva Parenteral Medicines, Inc.	0703-4094	00703-4094-01
Palonosetron Hydrochloride	Palonosetron hydrochloride .25 mg/5mL	Injection, SolutionIntravenous	Sandoz Inc	0781-3312	00781-3312-7500781-3312-95
palonosetron hydrochloride	Palonosetron hydrochloride .25 mg/5mL	InjectionIntravenous	Cipla USA Inc.	69097-927	69097-0927-35