Prescription drug · ANDA
Ondansetron Hydrochloride NDC 55154-4453
Ondansetron hydrochloride 2 mg/mL · Solution · Intramuscular, Intravenous · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-4453-5 | 55154445305 | 5 VIAL in 1 BAG (55154-4453-5) / 2 mL in 1 VIALMarketed from Mar 13, 2013 |
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 Hydrochloride
- Generic name (nonproprietary)
- ondansetron hydrochloride
- Active ingredients
- Ondansetron hydrochloride — 2 mg/mL
- Dosage form
- Solution
- Route
- Intramuscular, Intravenous
- Labeler
- Cardinal Health 107, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078287
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 55154-4453_f61b876e-8d99-407b-89c0-118fa77c8987SPL ID f61b876e-8d99-407b-89c0-118fa77c8987SPL set ID 30107d6f-5128-484f-b713-65244a98dc67RxCUI 1740467UNII NMH84OZK2BUPC 0055154445351
- 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.
- NDC on a medical claim
N455154445305followed by a unit qualifier and the quantityPackage 55154-4453-05. 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)
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 injection is approved for patients aged 6 months and older. 1.2 Prevention of Postoperative Nausea and/or Vomiting Ondansetron injection is indi…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078287
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ondansetron Hydrochloride | Ondansetron hydrochloride 2 mg/mL | SolutionIntramuscular, Intravenous | Baxter Healthcare Corporation | 36000-012 |
- Source
- FDA NDC Directory via openFDA; FDA SPL via openFDA and DailyMed; Med-Code HCPCS directory (curated)
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.