Prescription drug · ANDA
Ondansetron NDC 68788-9559
Ondansetron 8 mg/1 · Tablet, Orally disintegrating · Oral · Preferred Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-9559-1 | 68788955901 | 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68788-9559-1)Marketed from Aug 27, 2013 | |
| 68788-9559-3 | 68788955903 | 3 BLISTER PACK in 1 CARTON (68788-9559-3) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Aug 27, 2013 | |
| 68788-9559-5 | 68788955905 | 5 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68788-9559-5)Marketed from Aug 27, 2013 |
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
- Preferred Pharmaceuticals, Inc.NDC labeler code 68788
- 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 68788-9559_f31d49c2-beda-452d-9f36-f1ef89a0eeaeSPL ID f31d49c2-beda-452d-9f36-f1ef89a0eeaeSPL set ID b9abd5ce-6aca-4fda-8f46-0bb5b7fdd5daRxCUI 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
N468788955901followed by a unit qualifier and the quantityPackage 68788-9559-01. 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 e…
Excerpt only. Read the full label for complete information.
About NDC 68788-9559
- What is NDC 68788-9559?
- 68788-9559 is the product NDC for Ondansetron, Ondansetron 8 mg/1 tablet, orally disintegrating, listed with the FDA by Preferred Pharmaceuticals, Inc.. 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?
- Preferred Pharmaceuticals, Inc., NDC labeler code 68788. 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 8 mg/1 | Tablet, Orally disintegratingOral | AvKARE | 42291-458 | 42291-0458-30 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | AvKARE | 42291-457 | 42291-0457-30 |
| 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 | HAWAII REPACK, INC. | 85534-0063 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Proficient Rx LP | 63187-526 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Rising Pharma Holdings, Inc. | 57237-078 |
| 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 4 mg/1 | Tablet, Orally disintegratingOral | A-S Medication Solutions | 50090-1201 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | NuCare Pharmaceuticals,Inc. | 68071-4881 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | A-S Medication Solutions | 50090-1200 |
| 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 4 mg/1 | Tablet, Orally disintegratingOral | Asclemed USA, Inc. | 76420-217 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | St. Mary's Medical Park Pharmacy | 60760-306 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Asclemed USA, Inc. | 76420-251 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Advanced Rx of Tennessee, LLC | 80425-0473 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Bryant Ranch Prepack | 71335-1731 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | NuCare Pharmaceuticals,Inc. | 68071-2763 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Bryant Ranch Prepack | 71335-1314 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Northwind Health Company, LLC | 51655-913 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | NuCare Pharmaceuticals,Inc. | 68071-5021 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | NuCare Pharmaceuticals,Inc. | 68071-1730 |
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