Prescription drug · ANDA
ondansetron NDC 55154-4567
Ondansetron 4 mg/1 · Tablet, Orally disintegrating · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-4567-0 | 55154456700 | 10 BLISTER PACK in 1 BAG (55154-4567-0) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Aug 2, 2007 |
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 — 4 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Cardinal Health 107, LLCNDC labeler code 55154
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077557
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 55154-4567_81d88c5e-97fe-4a43-a721-4b0bc5d70122SPL ID 81d88c5e-97fe-4a43-a721-4b0bc5d70122SPL set ID 26aff90c-49ea-46ac-bbf3-c188c2b061c9RxCUI 104894UNII 4AF302ESOSUPC 0055154456708
- 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 codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N455154456700followed by a unit qualifier and the quantityPackage 55154-4567-00. 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 is indicated for the prevention of nausea and vomiting associated with: • highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 . • initial and repeat courses of moderately emetogenic cancer chemotherapy. • radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. Ondansetron is also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetronis a 5-HT 3 receptor antagonist indicated for the prevention of: • nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 …
Excerpt only. Read the full label for complete information.
About NDC 55154-4567
- What is NDC 55154-4567?
- 55154-4567 is the product NDC for ondansetron, Ondansetron 4 mg/1 tablet, orally disintegrating, listed with the FDA by Cardinal Health 107, LLC. 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?
- Cardinal Health 107, LLC, NDC labeler code 55154. 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?
- Not in Med-Code's curated HCPCS directory. 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 8 mg/1 | Tablet, Orally disintegratingOral | AvKARE | 42291-458 | 42291-0458-30 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | AvKARE | 42291-457 | 42291-0457-30 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | St. Mary's Medical Park Pharmacy | 60760-936 | 60760-0936-10 |
Other NDCs under ANDA 077557
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 | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Proficient Rx LP | 63187-670 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Proficient Rx LP | 63187-693 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Bryant Ranch Prepack | 63629-4306 |
| ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | NuCare Pharmaceuticals,Inc. | 68071-5230 |
| ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | NuCare Pharmaceuticals,Inc. | 68071-2284 |
| ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Sun Pharmaceutical Industries, Inc. | 62756-240 |
| ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Sun Pharmaceutical Industries, Inc. | 62756-356 |