Prescription drug · ANDA
Ondansetron NDC 50090-1659
Ondansetron 4 mg/1 · Tablet, Orally disintegrating · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-1659-0 | 50090165900 | 1 BLISTER PACK in 1 CARTON (50090-1659-0) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Jan 23, 2015 |
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
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078152
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50090-1659_fd2dbbfa-eac0-4b0a-9e3a-3de00157100aSPL ID fd2dbbfa-eac0-4b0a-9e3a-3de00157100aSPL set ID 02ddd5f5-76d3-4f1c-9af3-d39e05a19c29RxCUI 104894UNII 4AF302ESOS
- 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
N450090165900followed by a unit qualifier and the quantityPackage 50090-1659-00. 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. Ondansetron is 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 50090-1659
- What is NDC 50090-1659?
- 50090-1659 is the product NDC for Ondansetron, Ondansetron 4 mg/1 tablet, orally disintegrating, listed with the FDA by A-S Medication Solutions. 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?
- A-S Medication Solutions, NDC labeler code 50090. 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 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 |
Other NDCs under ANDA 078152
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 8 mg/1 | Tablet, Orally disintegratingOral | NuCare Pharmaceuticals,Inc | 68071-3926 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | PD-Rx Pharmaceuticals, Inc. | 43063-273 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | AvKARE | 42291-457 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | AvKARE | 42291-458 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | BluePoint Laboratories | 68001-246 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | BluePoint Laboratories | 68001-247 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Preferred Pharmaceuticals Inc. | 68788-8666 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | REMEDYREPACK INC. | 70518-3512 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | St. Mary's Medical Park Pharmacy | 60760-936 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | NuCare Pharmaceuticals,Inc. | 68071-4115 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Preferred Pharmaceuticals Inc. | 68788-4133 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Advanced Rx of Tennessee, LLC | 80425-0469 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Bryant Ranch Prepack | 71335-9726 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | NuCare Pharmaceuticals,Inc. | 68071-2718 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0222 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0227 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | A-S Medication Solutions | 50090-1658 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | REMEDYREPACK INC. | 70518-4685 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | NuCare Pharmaceuticals,Inc. | 68071-2901 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Proficient Rx LP | 63187-199 |
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