Ondansetron (ondansetron hydrochloride) NDC 76045-216

NDC codes

FDA NDC Directory

Product NDC (as listed)76045-216Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76045-0216Add 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
76045-216-20	76045021620	24 BLISTER PACK in 1 CARTON (76045-216-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-216-00) / 2 mL in 1 SYRINGE, GLASSMarketed from May 31, 2022

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/2mL
Dosage form: Injection, Solution
Route: Intramuscular, Intravenous
Labeler: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202253
Marketing start: May 31, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers: Product ID 76045-216_b71a45e3-2b90-4199-b88b-fef27cb394fcSPL ID b71a45e3-2b90-4199-b88b-fef27cb394fcSPL set ID d89017aa-b8c3-4fd2-8e68-44e2cfd6f290RxCUI 1314133UNII 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

N476045021620 followed by a unit qualifier and the quantity

Package 76045-0216-20. 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 Aug 16, 2023.

Indications (excerpt from the label)

Ondansetron Injection is a 5-HT 3 receptor antagonist indicated for the prevention of: nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. ( 1.1 ) postoperative nausea and/or vomiting. ( 1.2 ) 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202253

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

FDA NDC Directory listings under ANDA 202253
Product	Strength	Form · route	Labeler	Product NDC
Ondansetronondansetron hydrochloride	Ondansetron hydrochloride 4 mg/2mL	Injection, SolutionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	76045-103