Prescription drug · ANDA
Ondansetron NDC 83980-013
Ondansetron 8 mg/1 · Tablet, Orally disintegrating · Oral · Ipca Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83980-013-01 | 83980001301 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (83980-013-01)Marketed from Jun 19, 2025 | |
| 83980-013-10 | 83980001310 | 1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (83980-013-10)Marketed from Jun 19, 2025 | |
| 83980-013-13 | 83980001313 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (83980-013-13)Marketed from Jun 19, 2025 | |
| 83980-013-83 | 83980001383 | 3 BLISTER PACK in 1 CARTON (83980-013-83) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Jun 19, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
- Ipca Laboratories Limited
- 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 83980-013_3582cf26-d9a0-4b93-93a1-d1824e55fc19SPL ID 3582cf26-d9a0-4b93-93a1-d1824e55fc19SPL set ID 8e24f935-87fe-4b6a-b265-60b1039f38d5RxCUI 104894, 312087UNII 4AF302ESOSUPC 0383980012134, 0383980013131
- 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
N483980001301followed by a unit qualifier and the quantityPackage 83980-0013-01. 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 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 |
| Ondansetron | Ondansetron 8 mg/1 | Tablet, Orally disintegratingOral | Bryant Ranch Prepack | 71335-2973 |