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NDC 67457-0390-54 Zoledronic acid 4 mg/5mL Details
Zoledronic acid 4 mg/5mL
Zoledronic acid is a INTRAVENOUS INJECTION, SOLUTION, CONCENTRATE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Institutional LLC. The primary component is ZOLEDRONIC ACID.
MedlinePlus Drug Summary
Zoledronic acid (Reclast) is used to prevent or treat osteoporosis (condition in which the bones become thin and weak and break easily) in women who have undergone menopause ('change of life,' end of regular menstrual periods). Zoledronic acid (Reclast) is also used to treat osteoporosis in men, and to prevent or treat osteoporosis in men and women who are taking glucocorticoids (a type of corticosteroid medication that may cause osteoporosis). Zoledronic acid (Reclast) is also used to treat Paget's disease of bone (a condition in which the bones are soft and weak and may be deformed, painful, or easily broken). Zoledronic acid (Zometa) is used to treat high levels of calcium in the blood that may be caused by certain types of cancer. Zoledronic acid (Zometa) is also used along with cancer chemotherapy to treat bone damage caused by multiple myeloma [cancer that begins in the plasma cells (white blood cells that produce substances needed to fight infection)] or by cancer that began in another part of the body but has spread to the bones. Zoledronic acid (Zometa) is not cancer chemotherapy, and it will not slow or stop the spread of cancer. However, it can be used to treat bone disease in patients who have cancer. Zoledronic acid is in a class of medications called bisphosphonates. It works by slowing bone breakdown, increasing bone density (thickness), and decreasing the amount of calcium released from the bones into the blood.
Related Packages: 67457-0390-54Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Zoledronic Acid Injection
Product Information
NDC | 67457-0390 |
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Product ID | 67457-390_b1d56b68-c2b4-4f76-b04d-597a6b38ee31 |
Associated GPIs | 30042090001320 |
GCN Sequence Number | 051991 |
GCN Sequence Number Description | zoledronic acid VIAL 4 MG/5 ML INTRAVEN |
HIC3 | P4L |
HIC3 Description | BONE RESORPTION INHIBITORS |
GCN | 19476 |
HICL Sequence Number | 021845 |
HICL Sequence Number Description | ZOLEDRONIC ACID |
Brand/Generic | Generic |
Proprietary Name | Zoledronic acid |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Zoledronic acid |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | INJECTION, SOLUTION, CONCENTRATE |
Route | INTRAVENOUS |
Active Ingredient Strength | 4 |
Active Ingredient Units | mg/5mL |
Substance Name | ZOLEDRONIC ACID |
Labeler Name | Mylan Institutional LLC |
Pharmaceutical Class | Bisphosphonate [EPC], Diphosphonates [CS] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA202650 |
Listing Certified Through | 2024-12-31 |
Package
NDC 67457-0390-54 (67457039054)
NDC Package Code | 67457-390-54 |
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Billing NDC | 67457039054 |
Package | 1 VIAL in 1 CARTON (67457-390-54) / 5 mL in 1 VIAL |
Marketing Start Date | 2014-03-10 |
NDC Exclude Flag | N |
Pricing Information | N/A |