Ondansetron NDC 65162-691

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-691Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0691Add 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
65162-691-19	65162069119	10 CUP, UNIT-DOSE in 1 TRAY (65162-691-19) / 5 mL in 1 CUP, UNIT-DOSE (65162-691-37)Marketed from Dec 17, 2010
65162-691-79	65162069179	50 mL in 1 BOTTLE (65162-691-79)Marketed from Dec 17, 2010

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
Active ingredients: Ondansetron hydrochloride — 4 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091483
Marketing start: Dec 17, 2010
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers: Product ID 65162-691_7421d60d-7d82-4ec5-885a-255c507c32a4SPL ID 7421d60d-7d82-4ec5-885a-255c507c32a4SPL set ID 38435346-d505-4bdd-bbc6-a7bcba411033RxCUI 312085UNII NMH84OZK2BUPC 0365162691795
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

N465162069119 followed by a unit qualifier and the quantity

Package 65162-0691-19. 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 Sep 23, 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 oral solution is a 5-HT 3 receptor antagonist indicated for the prevention of: nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin grea…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 091483

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

FDA NDC Directory listings under ANDA 091483
Product	Strength	Form · route	Labeler	Product NDC
Ondansetron	Ondansetron hydrochloride 4 mg/5mL	SolutionOral	AvPAK	50268-647
Ondansetron	Ondansetron hydrochloride 4 mg/5mL	SolutionOral	American Health Packaging	60687-252
Ondansetron	Ondansetron hydrochloride 4 mg/5mL	SolutionOral	ATLANTIC BIOLOGICALS CORP.	17856-0691