Prescription drug · ANDA
Ondansetron NDC 67296-2119
Ondansetron hydrochloride 4 mg/1 · Tablet, Film coated · Oral · Redpharm Drug
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67296-2119-3 | 67296211903 | 30 TABLET, FILM COATED in 1 BOTTLE (67296-2119-3)Marketed from Jun 25, 2007 |
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
- Redpharm Drug
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077535
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 67296-2119_4698a594-cf21-0365-e063-6294a90a8784SPL ID 4698a594-cf21-0365-e063-6294a90a8784SPL set ID 300b1916-a3d8-0220-e063-6394a90a6f55RxCUI 198052UNII NMH84OZK2BUPC 0368462158111, 0368462106303
- 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
N467296211903followed by a unit qualifier and the quantityPackage 67296-2119-03. 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 077535
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 hydrochloride 4 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-105 |
| Ondansetron | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-106 |
| Ondansetron | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-770 |