NDC 0404-9912 Midazolam

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

Product Information

NDC Product Code:
0404-9912
Proprietary Name:
Midazolam
Non-Proprietary Name: [1]
Midazolam
Substance Name: [2]
Midazolam Hydrochloride
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.
  • Labeler Name: [5]
    Henry Schein, Inc.
    Labeler Code:
    0404
    FDA Application Number: [6]
    ANDA075154
    DEA Schedule: [7]
    Schedule IV (CIV) Substances
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    01-13-2022
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0404-9912-10

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

    Product Details

    What is NDC 0404-9912?

    The NDC code 0404-9912 is assigned by the FDA to the product Midazolam which is a human prescription drug product labeled by Henry Schein, Inc.. The product's dosage form is injection, solution and is administered via intramuscular; intravenous form. The product is distributed in a single package with assigned NDC code 0404-9912-10 1 vial in 1 bag / 10 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 Midazolam?

    This medication is used by people with epilepsy to treat a certain type of serious seizure that doesn't stop (seizure clusters). Midazolam belongs to a class of drugs known as benzodiazepines. It may work by increasing the effect of a certain substance in your body (GABA), which helps calm the brain and nerves.

    What are Midazolam 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.
    • MIDAZOLAM HYDROCHLORIDE 1 mg/mL - A short-acting hypnotic-sedative drug with anxiolytic and amnestic properties. It is used in dentistry, cardiac surgery, endoscopic procedures, as preanesthetic medication, and as an adjunct to local anesthesia. The short duration and cardiorespiratory stability makes it useful in poor-risk, elderly, and cardiac patients. It is water-soluble at pH less than 4 and lipid-soluble at physiological pH.

    Which are Midazolam UNII Codes?

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

    Which are Midazolam 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 Midazolam?

    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: 311700 - midazolam 1 MG/ML Injectable Solution
    • RxCUI: 311700 - midazolam (as midazolam hydrochloride) 1 MG/ML Injectable Solution

    Which are the Pharmacologic Classes for Midazolam?

    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

    Midazolam Injection


    Midazolam injection is used before medical procedures and surgery to cause drowsiness, relieve anxiety, and prevent any memory of the event. It is also sometimes given as part of the anesthesia during surgery to produce a loss of consciousness. Midazolam injection is also used to cause a state of decreased consciousness in seriously ill people in intensive care units (ICU) who are breathing with the help of a machine. Midazolam injection is in a class of medications called benzodiazepines. It works by slowing activity in the brain to allow relaxation and decreased consciousness.
    [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.

    [7] What is the Drug Enforcement Administration (DEA) CIV Schedule? - This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

    [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".