| Product NDC: | 53150-871 |
| Proprietary Name: | Zoledronic Acid |
| Non Proprietary Name: | Zoledronic Acid |
| Active Ingredient(s): | 4 mg/5mL & nbsp; Zoledronic Acid |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, SOLUTION, CONCENTRATE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 53150-871 |
| Labeler Name: | Amneal-Agila, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA202650 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20120423 |
| Package NDC: | 53150-871-01 |
| Package Description: | 1 VIAL, SINGLE-USE in 1 CARTON (53150-871-01) > 5 mL in 1 VIAL, SINGLE-USE |
| NDC Code | 53150-871-01 |
| Proprietary Name | Zoledronic Acid |
| Package Description | 1 VIAL, SINGLE-USE in 1 CARTON (53150-871-01) > 5 mL in 1 VIAL, SINGLE-USE |
| Product NDC | 53150-871 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Zoledronic Acid |
| Dosage Form Name | INJECTION, SOLUTION, CONCENTRATE |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20120423 |
| Marketing Category Name | ANDA |
| Labeler Name | Amneal-Agila, LLC |
| Substance Name | ZOLEDRONIC ACID |
| Strength Number | 4 |
| Strength Unit | mg/5mL |
| Pharmaceutical Classes | Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] |