Ondansetron
- Product NDC
- 42291-458
- 11-digit product format
- 422910458
- Labeler code
- 42291
- Product ID
- 42291-458_43cb3193-0685-d065-e063-6394a90afd47
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA078152
- Marketing category
- ANDA
- Marketing start
- 2025-11-17
- Substance
- ONDANSETRON
- Active strength
- 8 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ondansetron
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ONDANSETRON | 8 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4AF302ESOS |
| Rxcui | 104894, 312087 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42291-458-30 | Ondansetron | 30 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 30 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42291-458-30 | 42291045830 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (42291-458-30) | 2025-11-17 | No | No | Current |