Product NDC: | 0078-0435 |
Proprietary Name: | Reclast |
Non Proprietary Name: | zoledronic acid |
Active Ingredient(s): | 5 mg/100mL & nbsp; zoledronic acid |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0078-0435 |
Labeler Name: | Novartis Pharmaceuticals Corporation |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021817 |
Marketing Category: | NDA |
Start Marketing Date: | 20070401 |
Package NDC: | 0078-0435-61 |
Package Description: | 100 mL in 1 BOTTLE (0078-0435-61) |
NDC Code | 0078-0435-61 |
Proprietary Name | Reclast |
Package Description | 100 mL in 1 BOTTLE (0078-0435-61) |
Product NDC | 0078-0435 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | zoledronic acid |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20070401 |
Marketing Category Name | NDA |
Labeler Name | Novartis Pharmaceuticals Corporation |
Substance Name | ZOLEDRONIC ACID |
Strength Number | 5 |
Strength Unit | mg/100mL |
Pharmaceutical Classes | Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] |