Prescription drug · ANDA
Ondansetron NDC 51662-1678
Ondansetron hydrochloride 4 mg/1 · Tablet, Film coated · Oral · HF Acquisition Co LLC, DBA HealthFirst
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51662-1678-1 | 5166216780151662167801 | 30 TABLET, FILM COATED in 1 BOTTLE (51662-1678-1)Marketed from Dec 26, 2006 |
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 hydrochloride — 4 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- HF Acquisition Co LLC, DBA HealthFirstNDC labeler code 51662
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076183
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 51662-1678_4dcd1e4c-6a9d-7ac6-e063-6394a90a39bfSPL ID 4dcd1e4c-6a9d-7ac6-e063-6394a90a39bfSPL set ID 4dcd1e4c-6a9c-7ac6-e063-6394a90a39bfRxCUI 198052UNII NMH84OZK2B
- 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
N451662167801followed by a unit qualifier and the quantityPackage 51662-1678-01. 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 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/m2 . 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 tablets are also indicated for the prevention of postoperative nausea and/or vomiting.
Excerpt only. Read the full label for complete information.
About NDC 51662-1678
- What is NDC 51662-1678?
- 51662-1678 is the product NDC for Ondansetron, Ondansetron hydrochloride 4 mg/1 tablet, film coated, listed with the FDA by HF Acquisition Co LLC, DBA HealthFirst. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ondansetron.
- What is the active ingredient?
- Ondansetron hydrochloride.
- Who is the labeler?
- HF Acquisition Co LLC, DBA HealthFirst, NDC labeler code 51662. 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 076183
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 |
|---|---|---|---|---|
| ondansetronondansetron hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-7879 |
| ondansetronondansetron hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-3551 |
| Ondansetron | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | HF Acquisition Co LLC, DBA HealthFirst | 51662-1539 |
| Ondansetronondansetron hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Limited | 55111-154 |
| Ondansetronondansetron hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Limited | 55111-153 |
| ondansetron hydrochloride | Ondansetron hydrochloride 16 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Limited | 55111-155 |
| Ondansetronondansetron hydrochloride | Ondansetron hydrochloride 24 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Limited | 55111-156 |
| ondansetronondansetron hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6551 |
| ondansetronondansetron hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6552 |
| ondansetron hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8185 |