Product NDC: | 55150-125 |
Proprietary Name: | Ondansetron |
Non Proprietary Name: | Ondansetron Hydrochloride |
Active Ingredient(s): | 2 mg/mL & nbsp; Ondansetron Hydrochloride |
Administration Route(s): | INTRAMUSCULAR; INTRAVENOUS |
Dosage Form(s): | INJECTION, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 55150-125 |
Labeler Name: | AuroMedics Pharma LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA202600 |
Marketing Category: | ANDA |
Start Marketing Date: | 20121221 |
Package NDC: | 55150-125-02 |
Package Description: | 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-125-02) > 2 mL in 1 VIAL, SINGLE-DOSE |
NDC Code | 55150-125-02 |
Proprietary Name | Ondansetron |
Package Description | 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-125-02) > 2 mL in 1 VIAL, SINGLE-DOSE |
Product NDC | 55150-125 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Ondansetron Hydrochloride |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | INTRAMUSCULAR; INTRAVENOUS |
Start Marketing Date | 20121221 |
Marketing Category Name | ANDA |
Labeler Name | AuroMedics Pharma LLC |
Substance Name | ONDANSETRON HYDROCHLORIDE |
Strength Number | 2 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] |