NDC 61703-324 Pamidronate Disodium

Injection, Solution Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
61703-324
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
Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
  • Labeler Name: [5]
    Hospira, Inc.
    Labeler Code:
    61703
    FDA Application Number: [6]
    ANDA075841
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    10-01-2005
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 61703-324-18

    Package Description: 1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE

    Product Details

    What is NDC 61703-324?

    The NDC code 61703-324 is assigned by the FDA to the product Pamidronate Disodium which is a human prescription drug product labeled by Hospira, Inc.. The product's dosage form is injection, solution and is administered via intravenous form. The product is distributed in a single package with assigned NDC code 61703-324-18 1 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Pamidronate Disodium?

    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 Pamidronate Disodium Active Ingredients?

    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 Pamidronate Disodium UNII Codes?

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

    Which are Pamidronate Disodium Inactive Ingredients 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 Pamidronate Disodium?

    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 for Pamidronate Disodium?

    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.

    * Please review the disclaimer below.

    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.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".