NDC 11704-370 Cyanokit

Hydroxocobalamin Injection, Powder, Lyophilized, For Solution Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
11704-370
Proprietary Name:
Cyanokit
Non-Proprietary Name: [1]
Hydroxocobalamin
Substance Name: [2]
Hydroxocobalamin
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
  • Labeler Name: [5]
    Meridian Medical Technologies, Inc.
    Labeler Code:
    11704
    FDA Application Number: [6]
    NDA022041
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    10-01-2011
    End Marketing Date: [10]
    05-24-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 11704-370-01

    Package Description: 1 VIAL, GLASS in 1 CARTON / 250 mL in 1 VIAL, GLASS

    Product Details

    What is NDC 11704-370?

    The NDC code 11704-370 is assigned by the FDA to the product Cyanokit which is a human prescription drug product labeled by Meridian Medical Technologies, Inc.. The generic name of Cyanokit is hydroxocobalamin. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form. The product is distributed in a single package with assigned NDC code 11704-370-01 1 vial, glass in 1 carton / 250 ml in 1 vial, glass. 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 Cyanokit?

    Hydroxocobalamin is a man-made injectable form of vitamin B12 used to treat low levels (deficiency) of this vitamin. Vitamin B12 helps your body use fat and carbohydrates for energy and make new protein. It is also important for normal blood, cells, and nerves. Most people get enough vitamin B12 in their diet, but a deficiency may occur in certain health conditions (e.g., poor nutrition, stomach/intestinal problems, infection, cancer). Serious vitamin B12 deficiency may result in anemia, stomach problems, and nerve damage.

    What are Cyanokit 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.
    • HYDROXOCOBALAMIN 5 g/250mL - Injectable form of VITAMIN B 12 that has been used therapeutically to treat VITAMIN B 12 DEFICIENCY.

    Which are Cyanokit UNII Codes?

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

    Which are Cyanokit 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 Cyanokit?

    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 Cyanokit?

    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

    Cyanocobalamin Injection


    Cyanocobalamin injection is used to treat and prevent a lack of vitamin B12 that may be caused by any of the following: pernicious anemia (lack of a natural substance needed to absorb vitamin B12 from the intestine); certain diseases, infections, or medications that decrease the amount of vitamin B12 absorbed from food; or a vegan diet (strict vegetarian diet that does not allow any animal products, including dairy products and eggs). Lack of vitamin B12 may cause anemia (condition in which the red blood cells do not bring enough oxygen to the organs) and permanent damage to the nerves. Cyanocobalamin injection also may be given as a test to see how well the body can absorb vitamin B12. Cyanocobalamin injection is in a class of medications called vitamins. Because it is injected straight into the bloodstream, it can be used to supply vitamin B12 to people who cannot absorb this vitamin through the intestine.
    [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.

    [10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

    [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".