Prescription drug · ANDA
Ondansetron NDC 63629-4306
Ondansetron 8 mg/1 · Tablet, Orally disintegrating · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-4306-0 | 63629430600 | 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-0)Marketed from Aug 20, 2010 | |
| 63629-4306-1 | 63629430601 | 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-1)Marketed from Aug 19, 2013 | |
| 63629-4306-2 | 63629430602 | 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-2)Marketed from Aug 19, 2013 | |
| 63629-4306-3 | 63629430603 | 5 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-3)Marketed from Aug 19, 2013 | |
| 63629-4306-4 | 63629430604 | 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-4)Marketed from Aug 20, 2010 | |
| 63629-4306-5 | 63629430605 | 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-5)Marketed from Aug 20, 2010 | |
| 63629-4306-6 | 63629430606 | 14 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-6)Marketed from Aug 20, 2010 | |
| 63629-4306-7 | 63629430607 | 60 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-7)Marketed from Aug 20, 2010 | |
| 63629-4306-8 | 63629430608 | 12 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-8)Marketed from Aug 20, 2010 | |
| 63629-4306-9 | 63629430609 | 90 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63629-4306-9)Marketed from Aug 20, 2010 |
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 — 8 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- 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 63629-4306_d33adc9e-77b0-4e55-90ab-0944938ccf1aSPL ID d33adc9e-77b0-4e55-90ab-0944938ccf1aSPL set ID 384a5cfb-05dd-2b79-73f4-a01a47a9eb3eRxCUI 198052, 312087UNII 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
N463629430600followed by a unit qualifier and the quantityPackage 63629-4306-00. 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 . (1) na…
Excerpt only. Read the full label for complete information.
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 | 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 | Cardinal Health 107, LLC | 55154-4567 |
| 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 |