Ondansetron Hydrochloride
- Product NDC
- 83008-074
- 11-digit product format
- 830080074
- Labeler code
- 83008
- Product ID
- 83008-074_f2685012-ffce-483e-b8ad-1846d9d2d6da
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA078539
- Marketing category
- ANDA
- Marketing start
- 2024-07-25
- Marketing end
- 2028-01-31
- Substance
- ONDANSETRON HYDROCHLORIDE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- 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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 83008-074-20 | 83008007420 | 20 TABLET, FILM COATED in 1 BOTTLE (83008-074-20) | 2024-07-25 | 2028-01-31 | No | No | Historical |
| 83008-074-30 | 83008007430 | 30 TABLET, FILM COATED in 1 BOTTLE (83008-074-30) | 2024-07-25 | 2028-01-31 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ondansetron Hydrochloride | Quality Care Products, LLC | 2024-12-19 | Human Prescription Drug Label | 4 |