Zoledronic Acid is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Breckenridge Pharmaceutical, Inc.. The primary component is Zoledronic Acid.
| Product ID | 51991-065_326e60af-bde2-4612-a182-e9554cec9da5 |
| NDC | 51991-065 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Zoledronic Acid |
| Generic Name | Zoledronic Acid |
| Dosage Form | Injection, Solution, Concentrate |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2020-05-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA202571 |
| Labeler Name | Breckenridge Pharmaceutical, Inc. |
| Substance Name | ZOLEDRONIC ACID |
| Active Ingredient Strength | 4 mg/5mL |
| Pharm Classes | Diphosphonates [CS],Bisphosphonate [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2017-09-15 |
| Marketing End Date | 2022-05-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA202571 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-05-01 |
| Marketing End Date | 2020-05-02 |
| Marketing Category | ANDA |
| Application Number | ANDA091170 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2017-09-15 |
| Ingredient | Strength |
|---|---|
| ZOLEDRONIC ACID | 4 mg/5mL |
| SPL SET ID: | 2cf16c47-4c68-423e-a596-d0b1d3c5e067 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0143-9642 | Zoledronic Acid | zoledronic acid |
| 0409-4215 | ZOLEDRONIC ACID | ZOLEDRONIC ACID |
| 0409-4228 | ZOLEDRONIC ACID | ZOLEDRONIC ACID |
| 0409-4229 | Zoledronic Acid | ZOLEDRONIC ACID |
| 16714-815 | Zoledronic Acid | zoledronic Acid |
| 16729-242 | Zoledronic acid | zoledronic acid |
| 17478-324 | Zoledronic Acid | Zoledronic Acid |
| 17478-327 | Zoledronic Acid | Zoledronic Acid |
| 23155-170 | Zoledronic acid | Zoledronic acid |
| 23155-186 | Zoledronic acid | Zoledronic acid |
| 23155-525 | Zoledronic acid | Zoledronic acid |
| 25021-801 | zoledronic acid | zoledronic acid |
| 25021-826 | zoledronic acid | zoledronic acid |
| 68001-366 | Zoledronic Acid | Zoledronic Acid |
| 68083-116 | Zoledronic Acid | Zoledronic Acid |
| 68083-142 | Zoledronic Acid | Zoledronic Acid |
| 68083-135 | Zoledronic Acid | Zoledronic Acid |
| 69097-399 | ZOLEDRONIC ACID | ZOLEDRONIC ACID |
| 70860-210 | Zoledronic Acid | Zoledronic Acid |
| 25021-830 | zoledronic acid | zoledronic acid |
| 42023-151 | Zoledronic Acid | Zoledronic Acid |
| 42023-167 | Zoledronic Acid | Zoledronic Acid |
| 42023-163 | Zoledronic Acid | Zoledronic Acid |
| 43598-331 | Zoledronic Acid | Zoledronic Acid |
| 43598-330 | Zoledronic Acid | Zoledronic Acid |
| 43598-255 | Zoledronic acid | Zoledronic acid |
| 45963-440 | Zoledronic Acid | Zoledronic Acid |
| 51991-065 | Zoledronic Acid | Zoledronic Acid |
| 51991-064 | Zoledronic Acid | Zoledronic Acid |
| 54288-100 | ZOLEDRONIC ACID | ZOLEDRONIC ACID |
| 55150-283 | Zoledronic Acid | Zoledronic Acid |
| 55111-685 | Zoledronic Acid | Zoledronic Acid |
| 55111-688 | Zoledronic Acid | Zoledronic Acid |
| 55150-266 | Zoledronic Acid | Zoledronic Acid |
| 55648-185 | Zoledronic Acid | Zoledronic Acid |
| 55648-186 | Zoledronic Acid | Zoledronic Acid |
| 60505-6110 | Zoledronic Acid | Zoledronic Acid |
| 63323-966 | Zoledronic Acid | Zoledronic Acid |
| 63323-961 | Zoledronic Acid | Zoledronic Acid |
| 64679-186 | Zoledronic Acid | Zoledronic Acid |
| 64679-185 | Zoledronic Acid | Zoledronic Acid |
| 67457-794 | Zoledronic Acid | Zoledronic Acid |
| 67457-390 | Zoledronic acid | Zoledronic acid |
| 67457-619 | Zoledronic Acid | Zoledronic Acid |
| 0078-0435 | Reclast | zoledronic acid |
| 0078-0387 | Zometa | zoledronic acid |
| 0078-0590 | Zometa | zoledronic acid |