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  4. NDC Product Code: 45802-491 Cyanocobalamin

NDC 45802-491 Cyanocobalamin

Spray Nasal - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 45802-491?
  4. Cyanocobalamin Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes

Product Information

NDC Product Code:
45802-491
Proprietary Name:
Cyanocobalamin
Non-Proprietary Name: [1]
Cyanocobalamin
Substance Name: [2]
Cyanocobalamin
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route(s): [4]
  • Nasal - Administration to the nose; administered by way of the nose.
    • Labeler Name: [5]
    Padagis Israel Pharmaceuticals Ltd
    Labeler Code:
    45802
    Product Label ID:
    971e5f30-55c2-4193-9dd8-b43a1862b92a
    FDA Application Number: [6]
    ANDA212458
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    12-28-2023
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 45802-491?

    The NDC code 45802-491 is assigned by the FDA to the product Cyanocobalamin which is a human prescription drug product labeled by Padagis Israel Pharmaceuticals Ltd. The product's dosage form is spray and is administered via nasal form. The product is distributed in a single package with assigned NDC code 45802-491-84 4 bottle, unit-dose in 1 carton / 1 spray in 1 bottle, unit-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 Cyanocobalamin?

    Cyanocobalamin Nasal Spray is indicated for:•Vitamin B12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement •Treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin B12 deficiency not due to pernicious anemia •Prevention of vitamin B12 deficiency in adult patients with vitamin B12 requirements in excess of normalLimitations of Use•Cyanocobalamin Nasal Spray should not be used for the vitamin B12 absorption test (Schilling test). •In patients with correctible or temporary causes of vitamin B12 deficiency, the benefit of continued long-term use of Cyanocobalamin Nasal Spray following adequate correction of vitamin B12 deficiency and underlying disease has not been established. •The effectiveness of Cyanocobalamin Nasal Spray in patients with active symptoms of nasal congestion, allergic rhinitis or upper respiratory infection has not been determined. Treatment with Cyanocobalamin Nasal Spray should be deferred until symptoms have subsided.

    What are Cyanocobalamin 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 Cyanocobalamin UNII Codes?

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

    Which are Cyanocobalamin 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 Cyanocobalamin?

    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 Cyanocobalamin?

    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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    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".