What is NDC 83831-105?

83831-105 is the product NDC for posfrea (palonosetron), Palonosetron hydrochloride .25 mg/5mL injection, solution, listed with the FDA by Avyxa Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Avyxa Pharma, LLC, NDC labeler code 83831. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for posfrea?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

posfrea NDC 83831-105 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)83831-105Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83831-0105Add 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
83831-105-01	8383101050183831010501	1 VIAL, SINGLE-DOSE in 1 CARTON (83831-105-01) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 30, 2024

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): posfrea
Generic name (nonproprietary): palonosetron
Active ingredients: Palonosetron hydrochloride — .25 mg/5mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Avyxa Pharma, LLCNDC labeler code 83831
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 203050
Marketing start: Sep 30, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers: Product ID 83831-105_2f9cbcbc-86ee-49e4-a98a-d7fa286a32b8SPL ID 2f9cbcbc-86ee-49e4-a98a-d7fa286a32b8SPL set ID 13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a7RxCUI 1728050, 1728055, 2688837, 2688839UNII 23310D4I19UPC 0383831105015
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

N483831010501 followed by a unit qualifier and the quantity

Package 83831-0105-01. 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 Apr 29, 2025.

Indications (excerpt from the label)

POSFREA 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 postoperative period, POSFREA is reco…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 83831-105

What is NDC 83831-105?: 83831-105 is the product NDC for posfrea (palonosetron), Palonosetron hydrochloride .25 mg/5mL injection, solution, listed with the FDA by Avyxa Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: posfrea (Palonosetron).
What is the active ingredient?: Palonosetron hydrochloride.
Who is the labeler?: Avyxa Pharma, LLC, NDC labeler code 83831. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for posfrea?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

posfrea (Palonosetron) NDC 83831-105