Ondansetron Hydrochloride
- Product NDC
- 51655-813
- 11-digit product format
- 516550813
- Labeler code
- 51655
- Product ID
- 51655-813_4bbb7666-8259-6d09-e063-6394a90a08e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA078539
- Marketing category
- ANDA
- Marketing start
- 2021-06-10
- 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
- 2027-12-31
- 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 |
|---|
| 51655-813-54 | 51655081354 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-813-54) | 2021-06-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ondansetron Hydrochloride | Northwind Health Company, LLC | 2026-01-01 | HUMAN PRESCRIPTION DRUG LABEL | 5 |