Pamidronate Disodium Injection
NDC 67457-430

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 67457-430?
  4. Pamidronate Disodium 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

Pamidronate Disodium is a ANDA-approved product labeled by Mylan Institutional Llc. Pamidronate is used to treat high blood calcium levels and certain bone problems (bone metastases/lesions) that may occur with some types of cancer. It is supplied as a injection for intravenous administration. This product entry covers the primary NDC 67457-430 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
67457-430
Proprietary Name:
Pamidronate Disodium
Non-Proprietary Name: [1]
Pamidronate Disodium
Substance Name: [2]
Pamidronate Disodium
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]
Mylan Institutional Llc
Labeler Code:
67457
Product Label ID:
c2ca033e-fa5f-4141-b702-11f8b4303da1
FDA Application Number: [6]
ANDA078520
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
05-10-2011
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 67457-430?

The NDC code 67457-430 is assigned by the FDA to the product Pamidronate Disodium. This pharmaceutical product is labeled by Mylan Institutional Llc 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: 67457-430-10. 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?

Pamidronate is used to treat high blood calcium levels and certain bone problems (bone metastases/lesions) that may occur with some types of cancer. It is also used to treat a certain type of bone disease (Paget's disease) that causes abnormal and weak bones. Pamidronate belongs to a class of drugs known as bisphosphonates. It works by slowing the release of calcium from bones to lower blood calcium levels, reducing the risk of broken bones (fractures) and reducing bone pain.

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.
  • PAMIDRONATE DISODIUM 3 mg/mL - An aminobisphosphonate that inhibits BONE RESORPTION and is used for the treatment of osteolytic lesions, bone pain, and severe HYPERCALCEMIA associated with malignancies.

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

Pamidronate Injection


Pamidronate is used to treat high levels of calcium in the blood that may be caused by certain types of cancer. Pamidronate is also used along with cancer chemotherapy to treat bone damage caused by multiple myeloma (cancer that begins in the plasma cells [a type of white blood cell that produces substances needed to fight infection]) or by breast cancer that has spread to the bones. Pamidronate is also used to treat Paget's disease (a condition in which the bones are soft and weak and may be deformed, painful, or easily broken). Pamidronate injection 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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* Please review the full disclaimer at the bottom of this page.

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".