Prescription drug · ANDA
Ondansetron NDC 71335-2973
Ondansetron 8 mg/1 · Tablet, Orally disintegrating · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2973-1 | 71335297301 | 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2973-1)Marketed from Nov 6, 2025 | |
| 71335-2973-2 | 71335297302 | 60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2973-2)Marketed from Nov 6, 2025 | |
| 71335-2973-3 | 71335297303 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2973-3)Marketed from Nov 6, 2025 | |
| 71335-2973-4 | 71335297304 | 14 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2973-4)Marketed from Nov 6, 2025 | |
| 71335-2973-5 | 71335297305 | 12 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2973-5)Marketed from Nov 6, 2025 | |
| 71335-2973-6 | 71335297306 | 10 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2973-6)Marketed from Nov 6, 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 — 8 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209389
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 71335-2973_0d752116-b9e4-4ee6-a395-0e4a83f892dcSPL ID 0d752116-b9e4-4ee6-a395-0e4a83f892dcSPL set ID 7949c245-b79f-4eaf-a75f-9a17bd7bd307RxCUI 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
N471335297301followed by a unit qualifier and the quantityPackage 71335-2973-01. 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 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 ) nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. ( 1 ) nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. ( 1 ) postoperative nausea and/or vomiting. ( 1 ) Ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting associated with: highly emetogenic cancer c…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209389
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 | Ipca Laboratories Limited | 83980-013 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Ipca Laboratories Limited | 83980-012 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Bryant Ranch Prepack | 71335-2974 |
| Ondansetron | Ondansetron 4 mg/1 | Tablet, Orally disintegratingOral | Bryant Ranch Prepack | 71335-2972 |