Ondansetron Hydrochloride
- Product NDC
- 68071-5047
- 11-digit product format
- 680715047
- Labeler code
- 68071
- Product ID
- 68071-5047_1b418113-cac0-842f-e063-6294a90a71fa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA078539
- Marketing category
- ANDA
- Marketing start
- 2007-07-31
- Substance
- ONDANSETRON HYDROCHLORIDE
- 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 |
|---|
| NMH84OZK2B | ONDANSETRON HYDROCHLORIDE | 103639-04-9 | ONDANSETRON HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-5047-3 | 68071504703 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-5047-3) | 2019-09-04 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ondansetron Hydrochloride | NuCare Pharmaceuticals,Inc. | 2024-06-19 | HUMAN PRESCRIPTION DRUG LABEL | 3 |