Zoledronic Acid Injection
NDC 68083-256

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 68083-256?
  4. Zoledronic Acid Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

Zoledronic Acid is a ANDA-approved product labeled by Gland Pharma Limited. This medication is used to treat high blood calcium levels (hypercalcemia) that may occur with cancer. It is supplied as a injection for intravenous administration. This product entry covers the primary NDC 68083-256 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
68083-256
Proprietary Name:
Zoledronic Acid
Non-Proprietary Name: [1]
Zoledronic Acid
Substance Name: [2]
Zoledronic Acid
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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Clinical Specifications

Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s): [4]
Intravenous - Administration within or into a vein or veins.

Labeler & Regulatory Data

Labeler Name: [5]
Gland Pharma Limited
Labeler Code:
68083
Product Label ID:
d761011b-edd6-4d3f-bacd-8607dc2414fc
FDA Application Number: [6]
ANDA209578
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
03-13-2017
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 68083-256?

The NDC code 68083-256 is assigned by the FDA to the product Zoledronic Acid. This pharmaceutical product is labeled by Gland Pharma Limited and is currently categorized as listed product. The medication is a injection administered via intravenous route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 68083-256-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

This medication is used to treat high blood calcium levels (hypercalcemia) that may occur with cancer. Zoledronic acid is also used with cancer chemotherapy to treat bone problems that may occur with multiple myeloma and other types of cancer (such as breast, lung) that have spread to the bones. Zoledronic acid belongs to a class of drugs known as bisphosphonates. It lowers high blood calcium levels by reducing the amount of calcium released from your bones into your blood. It also works by slowing the breakdown of your bones by cancer to prevent bone fractures.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ZOLEDRONIC ACID 5 mg/100mL - An imidobisphosphonate inhibitor of BONE RESORPTION that is used for the treatment of malignancy-related HYPERCALCEMIA; OSTEITIS DEFORMANS; and OSTEOPOROSIS.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Zoledronic Acid Injection


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.
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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".