Prescription drug · ANDA
Ondansetron NDC 50090-1201
Ondansetron 4 mg/1 · Tablet, Orally disintegrating · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-1201-0 | 50090120100 | 1 BLISTER PACK in 1 CARTON (50090-1201-0) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Nov 28, 2014 |
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 Solutions
- 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 50090-1201_b5faf670-f22b-4d1a-bb78-31b59d136d2fSPL ID b5faf670-f22b-4d1a-bb78-31b59d136d2fSPL set ID 251d7b9a-f935-42f7-b985-91b8bba7637bRxCUI 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
N450090120100followed by a unit qualifier and the quantityPackage 50090-1201-00. 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 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.
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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