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NDC 0037-0678 Gastrocrom

Cromolyn Sodium Liquid Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0037-0678?
  5. Gastrocrom Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

NDC Product Code:
0037-0678
Proprietary Name:
Gastrocrom
Non-Proprietary Name: [1]
Cromolyn Sodium
Substance Name: [2]
Cromolyn Sodium
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Meda Pharmaceuticals
    Labeler Code:
    0037
    Product Label ID:
    00623958-a8fe-47d1-a0d2-0aa4e2f7966e
    FDA Application Number: [6]
    NDA020479
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    05-01-2015
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)

    Product Packages

    NDC Code 0037-0678-96

    Package Description: 12 POUCH in 1 CARTON / 8 AMPULE in 1 POUCH (0037-0678-08) / 5 mL in 1 AMPULE

    Product Details

    What is NDC 0037-0678?

    The NDC code 0037-0678 is assigned by the FDA to the product Gastrocrom which is a human prescription drug product labeled by Meda Pharmaceuticals. The generic name of Gastrocrom is cromolyn sodium. The product's dosage form is liquid and is administered via oral form. The product is distributed in a single package with assigned NDC code 0037-0678-96 12 pouch in 1 carton / 8 ampule in 1 pouch (0037-0678-08) / 5 ml in 1 ampule. 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 Gastrocrom?

    This medication is used to treat mastocytosis, a disease that occurs when the body has too many mast cells. These normal body cells release substances (e.g., histamines) that are needed for normal body defense and healing, but when too many mast cells are present, they release too much of these substances. This can lead to symptoms such as diarrhea, stomach/abdominal pain, itching, rash, and flushing. Cromolyn belongs to a class of medications called mast cell stabilizers. It works by preventing mast cells from releasing the substances that can cause these skin and gut problems.

    What are Gastrocrom 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.
    • CROMOLYN SODIUM 20 mg/mL - A chromone complex that acts by inhibiting the release of chemical mediators from sensitized MAST CELLS. It is used in the prophylactic treatment of both allergic and exercise-induced asthma, but does not affect an established asthmatic attack.

    Which are Gastrocrom UNII Codes?

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

    Which are Gastrocrom 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 Gastrocrom?

    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:
    • RxCUI: 831261 - cromolyn sodium 100 MG in 5 mL Concentrate for Oral Solution
    • RxCUI: 831261 - cromolyn sodium 20 MG/ML Oral Solution
    • RxCUI: 831261 - cromolyn sodium 100 MG per 5 ML Concentrate for Oral Solution
    • RxCUI: 831269 - Gastrocrom 100 MG in 5 mL Concentrate for Oral Solution
    • RxCUI: 831269 - cromolyn sodium 20 MG/ML Oral Solution [Gastrocrom]

    Which are the Pharmacologic Classes for Gastrocrom?

    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.

    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".