Prescription drug · ANDA
Ondansetron NDC 70518-3512
Ondansetron 4 mg/1 · Tablet, Orally disintegrating · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3512-0 | 70518351200 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-0)Marketed from Sep 7, 2022 | |
| 70518-3512-1 | 70518351201 | 6 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-1)Marketed from Sep 29, 2022 | |
| 70518-3512-2 | 70518351202 | 10 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-2)Marketed from Oct 20, 2023 | |
| 70518-3512-5 | 70518351205 | 9 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-5)Marketed from Dec 23, 2023 | |
| 70518-3512-7 | 70518351207 | 15 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-7)Marketed from Mar 6, 2025 | |
| 70518-3512-8 | 70518351208 | 3 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-8)Marketed from Jul 24, 2025 |
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
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078152
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 70518-3512_58c5fe3c-eb79-bd8f-e063-6394a90aa925SPL ID 58c5fe3c-eb79-bd8f-e063-6394a90aa925SPL set ID c0d827d0-333f-4187-ac75-9dc7d34b6169RxCUI 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
N470518351200followed by a unit qualifier and the quantityPackage 70518-3512-00. 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. Ondansetron is 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 ) nau…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078152
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 | Cardinal Health 107, LLC | 55154-3680 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | St. Mary's Medical Park Pharmacy | 60760-654 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Northwind Health Company, LLC | 51655-008 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Bryant Ranch Prepack | 71335-2635 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Proficient Rx LP | 63187-256 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Advanced Rx of Tennessee, LLC | 80425-0469 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0222 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0227 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Glenmark Pharmaceuticals Inc., USA | 68462-157 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | NuCare Pharmaceuticals, Inc. | 68071-3268 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Glenmark Pharmaceuticals Inc., USA | 68462-158 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | NuCare Pharmaceuticals,Inc | 68071-3926 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | PD-Rx Pharmaceuticals, Inc. | 43063-273 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | AvKARE | 42291-458 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | AvKARE | 42291-457 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | BluePoint Laboratories | 68001-247 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | BluePoint Laboratories | 68001-246 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Preferred Pharmaceuticals Inc. | 68788-8666 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | St. Mary's Medical Park Pharmacy | 60760-936 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | NuCare Pharmaceuticals,Inc. | 68071-4115 |
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