Ondansetron NDC 51662-1366 · J-Code J2405

NDC codes

FDA NDC Directory

Product NDC (as listed)51662-1366Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51662-1366Add 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
51662-1366-1	51662136601	2 mL in 1 VIAL (51662-1366-1)Marketed from Dec 8, 2019

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 2 mg/mL
Dosage form: Injection
Route: Intramuscular, Intravenous
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076972
Marketing start: Dec 8, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers: Product ID 51662-1366_ef7bd6e6-d630-7e93-e053-2a95a90aef83SPL ID ef7bd6e6-d630-7e93-e053-2a95a90aef83SPL set ID 993cd1d7-70a1-a431-e053-2a95a90a5771RxCUI 1740467UNII 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 codeMed-Code curated

J2405 — Injection, ondansetron hydrochloride, per 1 mg

Billing unit: 1 mg. Units on the claim = dose given ÷ 1 mg.

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

N451662136601 followed by a unit qualifier and the quantity

Package 51662-1366-01. 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 Dec 10, 2022.

Indications (excerpt from the label)

1.1 Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Cancer Chemotherapy Ondansetron injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin [see CLINICAL STUDIES (14.1)]. Ondansetron is approved for patients aged 6 months and older. 1.2 Prevention of Postoperative Nausea and/or Vomiting Ondansetron injection is indicated for the prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur pos…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076972

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

FDA NDC Directory listings under ANDA 076972
Product	Strength	Form · route	Labeler	Product NDC
Ondansetronondansetron hydrochloride	Ondansetron hydrochloride 2 mg/mL	InjectionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	65219-323
Ondansetronondansetron hydrochloride	Ondansetron hydrochloride 2 mg/mL	InjectionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	63323-373