Prescription drug · ANDA
Ondansetron NDC 51655-913
Ondansetron 4 mg/1 · Tablet, Orally disintegrating · Oral · Northwind Health Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51655-913-20 | 51655091320 | 20 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-913-20)Marketed from Jun 3, 2022 | |
| 51655-913-53 | 51655091353 | 10 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-913-53)Marketed from Jan 22, 2021 | |
| 51655-913-54 | 51655091354 | 15 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-913-54)Marketed from Mar 15, 2023 |
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
- Northwind Health Company, LLCNDC labeler code 51655
- 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 51655-913_4a8dd8e9-dd5c-efb4-e063-6294a90a89d9SPL ID 4a8dd8e9-dd5c-efb4-e063-6294a90a89d9SPL set ID db9a0d22-9339-4319-e053-2a95a90a9592RxCUI 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
N451655091320followed by a unit qualifier and the quantityPackage 51655-0913-20. 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 emetogeni…
Excerpt only. Read the full label for complete information.
About NDC 51655-913
- What is NDC 51655-913?
- 51655-913 is the product NDC for Ondansetron, Ondansetron 4 mg/1 tablet, orally disintegrating, listed with the FDA by Northwind Health Company, LLC. It has 3 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?
- Northwind Health Company, LLC, NDC labeler code 51655. 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 8 mg/1 | Tablet, Orally disintegratingOral | Proficient Rx LP | 71205-713 |
| Ondansetron ODTondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Advanced Rx of Tennessee, LLC | 80425-0073 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Aurobindo Pharma Limited | 65862-391 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Bryant Ranch Prepack | 71335-1071 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Aurobindo Pharma Limited | 65862-390 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | NorthStar Rx LLC | 16714-200 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Proficient Rx LP | 63187-379 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | NorthStar Rx LLC | 16714-201 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | HF Acquisition Co LLC, DBA HealthFirst | 51662-1246 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Northwind Health Company, LLC | 51655-196 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Preferred Pharmaceuticals, Inc. | 68788-7565 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | NuCare Pharmaceuticals,Inc. | 68071-4834 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Preferred Pharmaceuticals, Inc. | 68788-7644 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | A-S Medication Solutions | 50090-1128 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | A-S Medication Solutions | 50090-2343 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Bryant Ranch Prepack | 71335-0650 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Rising Pharma Holdings, Inc. | 57237-077 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | HAWAII REPACK, INC. | 85534-0025 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Rising Pharma Holdings, Inc. | 57237-078 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | A-S Medication Solutions | 50090-1200 |
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