NDC Code | 53002-0600-1 |
Package Description | 3 TABLET, FILM COATED in 1 BOTTLE (53002-0600-1) |
Product NDC | 53002-0600 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Ondansetron |
Non-Proprietary Name | Ondansetron Hydrochloride |
Dosage Form | TABLET, FILM COATED |
Usage | ORAL |
Start Marketing Date | 20070625 |
Marketing Category Name | ANDA |
Application Number | ANDA077851 |
Manufacturer | RPK Pharmaceuticals, Inc. |
Substance Name | ONDANSETRON HYDROCHLORIDE |
Strength | 8 |
Strength Unit | mg/1 |
Pharmacy Classes | Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC] |