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NDC 69945-139 Pulmotech Maa

Kit For The Preparation Of Technetium Tc 99m Albumin Aggregated Injection, Powder, - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 69945-139?
  4. Pulmotech Maa Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

NDC Product Code:
69945-139
Proprietary Name:
Pulmotech Maa
Non-Proprietary Name: [1]
Kit For The Preparation Of Technetium Tc 99m Albumin Aggregated
Substance Name: [2]
Albumin Aggregated
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Powder, Lyophilized, For Suspension - A liquid preparation, intended for parenteral use that contains solids suspended in a suitable fluid medium and conforms in all respects to the requirements for Sterile Suspensions; the medicinal agents intended for the suspension are prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures.
Administration Route(s): [4]
  • Intraperitoneal - Administration within the peritoneal cavity.
  • Intravenous - Administration within or into a vein or veins.
    • Labeler Name: [5]
    Curium Us Llc
    Labeler Code:
    69945
    Product Label ID:
    a8b7adf0-2c6b-4acd-96d3-a099306951a0
    FDA Application Number: [6]
    BLA210089
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    03-20-2020
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 69945-139-20

    Package Description: 5 VIAL, MULTI-DOSE in 1 CELLO PACK / 15 mL in 1 VIAL, MULTI-DOSE (69945-139-10)

    NDC Code 69945-139-40

    Package Description: 30 VIAL, MULTI-DOSE in 1 CARTON / 15 mL in 1 VIAL, MULTI-DOSE (69945-139-10)

    Product Details

    What is NDC 69945-139?

    The NDC code 69945-139 is assigned by the FDA to the product Pulmotech Maa which is a human prescription drug product labeled by Curium Us Llc. The generic name of Pulmotech Maa is kit for the preparation of technetium tc 99m albumin aggregated. The product's dosage form is injection, powder, lyophilized, for suspension and is administered via intraperitoneal; intravenous form. The product is distributed in 2 packages with assigned NDC codes 69945-139-20 5 vial, multi-dose in 1 cello pack / 15 ml in 1 vial, multi-dose (69945-139-10), 69945-139-40 30 vial, multi-dose in 1 carton / 15 ml in 1 vial, multi-dose (69945-139-10). 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 Pulmotech Maa?

    Technetium Tc 99m Albumin Aggregated Injection is a radioactive diagnostic agent indicated for:Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients.Scintigraphy of peritoneovenous shunt as an aid in the evaluation of its patency in adults.

    What are Pulmotech Maa 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.

    Which are Pulmotech Maa UNII Codes?

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

    Which are Pulmotech Maa 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:

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    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".