Prescription drug · ANDA
ondansetron NDC 16729-298
Ondansetron 2 mg/mL · Injection · Intramuscular, Intravenous · Accord Healthcare, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16729-298-05 | 1672902980516729029805 | 20 mL in 1 VIAL (16729-298-05)Marketed from Oct 20, 2016 |
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 — 2 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Labeler
- Accord Healthcare, Inc.NDC labeler code 16729
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206846
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 16729-298_424e0911-305e-8eb5-e063-6294a90aaab3SPL ID 424e0911-305e-8eb5-e063-6294a90aaab3SPL set ID 35e0d160-813f-41d7-a382-d2cab6485d9cRxCUI 283504UNII 4AF302ESOSUPC 0316729298056
- 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
N416729029805followed by a unit qualifier and the quantityPackage 16729-0298-05. 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 indicate…
Excerpt only. Read the full label for complete information.
About NDC 16729-298
- What is NDC 16729-298?
- 16729-298 is the product NDC for ondansetron, Ondansetron 2 mg/mL injection, listed with the FDA by Accord Healthcare, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- ondansetron.
- What is the active ingredient?
- Ondansetron.
- Who is the labeler?
- Accord Healthcare, Inc., NDC labeler code 16729. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for ondansetron?
- 190 other product NDCs are listed under this name. See all ondansetron NDCs.
- Is there a related HCPCS / J-code?
- Yes: J2405, Injection, ondansetron hydrochloride, per 1 mg. See Billing references above.
Related NDCs: other ondansetron products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | REMEDYREPACK INC. | 70518-4685 | 70518-4685-00 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Preferred Pharmaceuticals Inc. | 68788-4133 | 68788-4133-0168788-4133-03 |
| Ondansetron | Ondansetron hydrochloride 4 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-4882 | 00121-4882-94 |
| Ondansetron | Ondansetron hydrochloride 4 mg/5mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0882 | 00121-0882-51 |
| Ondansetron | Ondansetron hydrochloride 2 mg/mL | InjectionIntramuscular, Intravenous | JVET PHARMACEUTICALS LLC | 86211-115 | 86211-0115-01 |
| Ondansetron | Ondansetron hydrochloride 4 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4588 | 70518-4588-00 |
| Ondansetron | Ondansetron hydrochloride 2 mg/mL | Injection, SolutionIntramuscular, Intravenous | Hospira, Inc. | 0409-2271 | 00409-2271-25 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | AvKARE | 42291-457 | 42291-0457-30 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | AvKARE | 42291-458 | 42291-0458-30 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | St. Mary's Medical Park Pharmacy | 60760-936 | 60760-0936-10 |