Ondansetron
- Product NDC
- 80425-0228
- 11-digit product format
- 804250228
- Labeler code
- 80425
- Product ID
- 80425-0228_36624551-9805-e3d9-e063-6294a90aa4f6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA090469
- Marketing category
- ANDA
- Marketing start
- 2023-01-11
- Substance
- ONDANSETRON
- Active strength
- 4 mg/1
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 4AF302ESOS | ONDANSETRON | 99614-02-5 | ONDANSETRON |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0228-1 | 80425022801 | 3 BLISTER PACK in 1 CARTON (80425-0228-1) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 3 blister pack | 2023-01-11 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ondansetron 4mg Tablet | Advanced Rx Pharmacy of Tennessee, LLC | 2025-05-30 | HUMAN PRESCRIPTION DRUG LABEL | 6 |