NDC 25021-609 Dihydroergotamine Mesylate

Injection, Solution Intramuscular; Intravenous; Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
25021-609
Proprietary Name:
Dihydroergotamine Mesylate
Non-Proprietary Name: [1]
Dihydroergotamine Mesylate
Substance Name: [2]
Dihydroergotamine Mesylate
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]
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Labeler Name: [5]
    Sagent Pharmaceuticals
    Labeler Code:
    25021
    FDA Application Number: [6]
    ANDA207264
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    09-15-2022
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 25021-609-01

    Package Description: 5 VIAL in 1 CARTON / 1 mL in 1 VIAL

    NDC Code 25021-609-02

    Package Description: 10 VIAL in 1 CARTON / 1 mL in 1 VIAL

    Product Details

    What is NDC 25021-609?

    The NDC code 25021-609 is assigned by the FDA to the product Dihydroergotamine Mesylate which is a human prescription drug product labeled by Sagent Pharmaceuticals. The product's dosage form is injection, solution and is administered via intramuscular; intravenous; subcutaneous form. The product is distributed in 2 packages with assigned NDC codes 25021-609-01 5 vial in 1 carton / 1 ml in 1 vial, 25021-609-02 10 vial in 1 carton / 1 ml in 1 vial. 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 Dihydroergotamine Mesylate?

    This medication is used to treat migraine headache attacks. It helps relieve headache pain and other symptoms such as sensitivity to light or sound. Prompt treatment allows you to get back to your normal routine sooner and may decrease your need for other pain medications. This medication is not used to prevent migraines from occurring. Dihydroergotamine belongs to a class of drugs known as ergot alkaloids. It may work by narrowing the blood vessels in the brain. It may also block other pain pathways in the brain.

    What are Dihydroergotamine Mesylate 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 Dihydroergotamine Mesylate UNII Codes?

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

    Which are Dihydroergotamine Mesylate 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 Dihydroergotamine Mesylate?

    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 Dihydroergotamine Mesylate?

    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

    Dihydroergotamine Injection


    Dihydroergotamine is used to treat migraine headaches (severe, throbbing headaches that sometimes are accompanied by nausea and sensitivity to sound and light) and cluster headaches (severe headaches usually on one side of the head or around one eye). Dihydroergotamine is in a class of medications called ergot alkaloids. It works by tightening blood vessels in the brain and by stopping the release of natural substances in the brain that cause swelling.
    [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".