Ondansetron
- Product NDC
- 68071-3713
- 11-digit product format
- 680713713
- Labeler code
- 68071
- Product ID
- 68071-3713_25535c84-cc6f-cc61-e063-6294a90ad761
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA078539
- Marketing category
- ANDA
- Marketing start
- 2021-04-06
- Substance
- ONDANSETRON HYDROCHLORIDE
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| NMH84OZK2B | ONDANSETRON HYDROCHLORIDE | 103639-04-9 | ONDANSETRON HYDROCHLORIDE |
| 4AF302ESOS | ONDANSETRON | 99614-02-5 | Ondansetron |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3713-3 | 68071371303 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3713-3) | 2024-10-25 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ondansetron | NuCare Pharmaceuticals, Inc. | 2024-10-25 | HUMAN PRESCRIPTION DRUG LABEL | 1 |