NDC codes

FDA NDC Directory
Product NDC (as listed)51662-1469Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51662-1469Add 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 NDC11-digit (billing)PackageCopy
51662-1469-1516621469012 mL in 1 VIAL, SINGLE-DOSE (51662-1469-1)Marketed from Dec 14, 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, Solution
Route
Intramuscular, Intravenous
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077548
Marketing start
Listing expires
Other FDA classes
Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers
Product ID 51662-1469_2b39dbc0-2d09-0a7f-e063-6394a90add31SPL ID 2b39dbc0-2d09-0a7f-e063-6394a90add31SPL set ID 99ac0a5e-dd2a-4352-e053-2a95a90a68fdRxCUI 1740467UNII NMH84OZK2B

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

N451662146901 followed by a unit qualifier and the quantity

Package 51662-1469-01. 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 .

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. 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 postoperatively. In patients in w…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077548

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

FDA NDC Directory listings under ANDA 077548
ProductStrengthForm · routeLabelerProduct NDC
OndansetronOndansetron hydrochloride 2 mg/mLInjection, SolutionIntramuscular, IntravenousMedical Purchasing Solutions, LLC71872-7162
OndansetronOndansetron hydrochloride 2 mg/mLInjection, SolutionIntramuscular, IntravenousHospira, Inc.0409-4755
OndansetronOndansetron hydrochloride 2 mg/mLInjection, SolutionIntramuscular, IntravenousHospira, Inc.0409-0009
OndansetronOndansetron hydrochloride 2 mg/mLInjection, SolutionIntramuscular, IntravenousHospira, Inc.0409-2271
OndansetronOndansetron hydrochloride 2 mg/mLInjection, SolutionIntramuscular, IntravenousCardinal Health 107, LLC55154-6976

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