Product NDC: | 0054-0064 |
Proprietary Name: | Ondansetron Hydrochloride |
Non Proprietary Name: | Ondansetron Hydrochloride |
Active Ingredient(s): | 4 mg/5mL & nbsp; Ondansetron Hydrochloride |
Administration Route(s): | ORAL |
Dosage Form(s): | SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0054-0064 |
Labeler Name: | Roxane Laboratories, Inc |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA076960 |
Marketing Category: | ANDA |
Start Marketing Date: | 20061226 |
Package NDC: | 0054-0064-47 |
Package Description: | 1 BOTTLE, GLASS in 1 CARTON (0054-0064-47) > 50 mL in 1 BOTTLE, GLASS |
NDC Code | 0054-0064-47 |
Proprietary Name | Ondansetron Hydrochloride |
Package Description | 1 BOTTLE, GLASS in 1 CARTON (0054-0064-47) > 50 mL in 1 BOTTLE, GLASS |
Product NDC | 0054-0064 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Ondansetron Hydrochloride |
Dosage Form Name | SOLUTION |
Route Name | ORAL |
Start Marketing Date | 20061226 |
Marketing Category Name | ANDA |
Labeler Name | Roxane Laboratories, Inc |
Substance Name | ONDANSETRON HYDROCHLORIDE |
Strength Number | 4 |
Strength Unit | mg/5mL |
Pharmaceutical Classes | Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] |