Prescription drug · ANDA
Ondansetron NDC 76420-056
Ondansetron 4 mg/1 · Tablet, Orally disintegrating · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-056-04 | 7642000560476420005604 | 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (76420-056-04)Marketed from Oct 29, 2020 | |
| 76420-056-06 | 7642000560676420005606 | 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (76420-056-06)Marketed from Aug 29, 2020 | |
| 76420-056-08 | 7642000560876420005608 | 8 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (76420-056-08)Marketed from Aug 28, 2026 | |
| 76420-056-10 | 7642000561076420005610 | 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (76420-056-10)Marketed from Feb 5, 2020 | |
| 76420-056-14 | 7642000561476420005614 | 14 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (76420-056-14)Marketed from Jan 10, 2026 | |
| 76420-056-20 | 7642000562076420005620 | 20 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (76420-056-20)Marketed from Feb 5, 2020 | |
| 76420-056-30 | 7642000563076420005630 | 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (76420-056-30)Marketed from Feb 5, 2020 |
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 — 4 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Asclemed USA, Inc.NDC labeler code 76420
- 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 76420-056_5cca502a-e9d9-a2ea-e063-6294a90a2678SPL ID 5cca502a-e9d9-a2ea-e063-6294a90a2678
- 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
N476420005604followed by a unit qualifier and the quantityPackage 76420-0056-04. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 76420-056
- What is NDC 76420-056?
- 76420-056 is the product NDC for Ondansetron, Ondansetron 4 mg/1 tablet, orally disintegrating, listed with the FDA by Asclemed USA, Inc.. It has 7 package NDCs, 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?
- Asclemed USA, Inc., NDC labeler code 76420. 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 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 | Preferred Pharmaceuticals, Inc. | 68788-7644 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | NuCare Pharmaceuticals,Inc. | 68071-4834 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Bryant Ranch Prepack | 71335-1071 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Rising Pharma Holdings, Inc. | 57237-077 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Preferred Pharmaceuticals, Inc. | 68788-9559 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Rising Pharma Holdings, Inc. | 57237-078 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | NuCare Pharmaceuticals,Inc. | 68071-4881 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Proficient Rx LP | 71205-713 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Direct Rx | 61919-986 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | REMEDYREPACK INC. | 70518-1551 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | St. Mary's Medical Park Pharmacy | 60760-306 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | PD-Rx Pharmaceuticals, Inc. | 43063-857 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Bryant Ranch Prepack | 71335-0650 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Proficient Rx LP | 63187-526 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | PD-Rx Pharmaceuticals, Inc. | 43063-870 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Northwind Health Company, LLC | 51655-809 |
| Ondansetron ODTondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Advanced Rx of Tennessee, LLC | 80425-0073 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | NuCare Pharmaceuticals,Inc. | 68071-2763 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | HAWAII REPACK, INC. | 85534-0025 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | NuCare Pharmaceuticals,Inc. | 68071-1730 |
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