Prescription drug · ANDA
Ondansetron NDC 71205-713
Ondansetron 8 mg/1 · Tablet, Orally disintegrating · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-713-10 | 71205071310 | 1 BLISTER PACK in 1 BAG (71205-713-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Nov 17, 2022 | |
| 71205-713-20 | 71205071320 | 2 BLISTER PACK in 1 BAG (71205-713-20) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Nov 17, 2022 | |
| 71205-713-30 | 71205071330 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71205-713-30)Marketed from Nov 21, 2022 | |
| 71205-713-60 | 71205071360 | 60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71205-713-60)Marketed from Nov 21, 2022 | |
| 71205-713-90 | 71205071390 | 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71205-713-90)Marketed from Nov 21, 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
- Active ingredients
- Ondansetron — 8 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090469
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 71205-713_35203011-d93c-4169-a9cb-90b6d20b146bSPL ID 35203011-d93c-4169-a9cb-90b6d20b146bSPL set ID 47e26779-9465-410c-96b3-091119ae62f2RxCUI 312087UNII 4AF302ESOSUPC 0371205713102
- 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
N471205071310followed by a unit qualifier and the quantityPackage 71205-0713-10. 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 orally disintegrating tablets are 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 orally disintegrating tablets also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron orally disintegrating tablets are a 5-HT 3 receptor antagonist indicated for the prevention of: • nausea and vomiting associated with highly e…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090469
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 | HF Acquisition Co LLC, DBA HealthFirst | 51662-1514 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Advanced Rx of Tennessee, LLC | 80425-0473 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Asclemed USA, Inc. | 76420-251 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | PD-Rx Pharmaceuticals, Inc. | 43063-857 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Proficient Rx LP | 63187-266 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | PD-Rx Pharmaceuticals, Inc. | 43063-870 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | A-S Medication Solutions | 50090-4632 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | NuCare Pharmaceuticals,Inc. | 68071-4570 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Cardinal Health 107, LLC | 55154-8339 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | NuCare Pharmaceuticals,Inc. | 68071-5167 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0228 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Sportpharm LLC | 85766-038 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Bryant Ranch Prepack | 71335-1071 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Aurobindo Pharma Limited | 65862-391 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Aurobindo Pharma Limited | 65862-390 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Proficient Rx LP | 63187-379 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | NorthStar Rx LLC | 16714-200 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | HF Acquisition Co LLC, DBA HealthFirst | 51662-1246 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | NorthStar Rx LLC | 16714-201 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Northwind Health Company, LLC | 51655-196 |
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