Ondansetron (ondansetron hydrochloride) NDC 65862-208

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-208Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0208Add 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
65862-208-04	65862020804	1 BOTTLE, PLASTIC in 1 CARTON (65862-208-04) / 50 mL in 1 BOTTLE, PLASTICMarketed from Nov 28, 2007
65862-208-50	65862020850	1 BOTTLE in 1 CARTON (65862-208-50) / 50 mL in 1 BOTTLEMarketed from Nov 28, 2007

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): Ondansetron
Generic name (nonproprietary): ondansetron hydrochloride
Active ingredients: Ondansetron hydrochloride — 4 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078776
Marketing start: Nov 28, 2007
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers: Product ID 65862-208_a839599f-f788-4039-9e34-b443d1c9849bSPL ID a839599f-f788-4039-9e34-b443d1c9849bSPL set ID cf10d256-dd89-4a91-a3ed-81db505a79c2RxCUI 312085UNII NMH84OZK2B
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N465862020804 followed by a unit qualifier and the quantity

Package 65862-0208-04. 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 Jul 8, 2025.

Indications (excerpt from the label)

Ondansetron oral solution is indicated for the prevention of nausea and vomiting associated with: highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 initial and repeat courses of moderately emetogenic cancer chemotherapy radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen Ondansetron oral solution is also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron is a 5-HT 3 receptor antagonist indicated for the prevention of: nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or eq…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078776

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

FDA NDC Directory listings under ANDA 078776
Product	Strength	Form · route	Labeler	Product NDC
Ondansetronondansetron hydrochloride	Ondansetron hydrochloride 4 mg/5mL	SolutionOral	Atlantic Biologics Corp.	17856-0672
Ondansetronondansetron hydrochloride	Ondansetron hydrochloride 4 mg/5mL	SolutionOral	NorthStar Rx LLC	16714-671
Ondansetronondansetron hydrochloride	Ondansetron hydrochloride 4 mg/5mL	SolutionOral	NuCare Pharmaceuticals,Inc.	68071-3611