Ondansetron Hydrochloride
- Product NDC
- 72789-034
- 11-digit product format
- 727890034
- Labeler code
- 72789
- Product ID
- 72789-034_3c6d1f46-ae20-8bc0-e063-6394a90a4a08
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ondansetron Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx 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 |
|---|
| 72789-034-12 | 72789003412 | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-034-12) | 2019-12-02 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ondansetron Hydrochloride | PD-Rx Pharmaceuticals, Inc. | 2025-08-15 | HUMAN PRESCRIPTION DRUG LABEL | 18 |