NDC 72252-510 Valtoco

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

Product Information

NDC Product Code:
72252-510
Proprietary Name:
Valtoco
Non-Proprietary Name: [1]
Diazepam
Substance Name: [2]
Diazepam
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]
    Neurelis, Inc
    Labeler Code:
    72252
    FDA Application Number: [6]
    NDA211635
    DEA Schedule: [7]
    Schedule IV (CIV) Substances
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    01-10-2020
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 72252-510-02

    Package Description: 2 BLISTER PACK in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE

    Price per Unit: $334.05299 per EA

    Product Details

    What is NDC 72252-510?

    The NDC code 72252-510 is assigned by the FDA to the product Valtoco which is a human prescription drug product labeled by Neurelis, Inc. The generic name of Valtoco is diazepam. 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 72252-510-02 2 blister pack in 1 carton / 1 vial, single-dose in 1 blister pack / .1 ml in 1 vial, single-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 Valtoco?

    This medication is used to treat episodes of increased seizures (such as cluster or breakthrough seizures) in people who are already taking medications to control their seizures. This product is only recommended for short-term treatment of seizure attacks. It is not for ongoing daily use to prevent seizures. Uncontrolled seizures can turn into serious (possibly fatal) seizures that do not stop (status epilepticus). This medication is not recommended for children younger than 6 months of age because of the risk of serious side effects. Diazepam works by calming the brain and nerves. It belongs to a class of drugs known as benzodiazepines.

    What are Valtoco 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.
    • DIAZEPAM 10 mg/.1mL - A benzodiazepine with anticonvulsant, anxiolytic, sedative, muscle relaxant, and amnesic properties and a long duration of action. Its actions are mediated by enhancement of GAMMA-AMINOBUTYRIC ACID activity.

    Which are Valtoco UNII Codes?

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

    What is the NDC to RxNorm Crosswalk for Valtoco?

    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 Valtoco?

    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

    Diazepam Nasal Spray


    Diazepam nasal spray is used for emergency situations to stop cluster seizures (episodes of increased seizure activity) in adults and children 6 years of age and older who are taking other medications to treat epilepsy (seizures). Diazepam is in a class of medications called benzodiazepines. It works by calming abnormal overactivity in the brain.
    [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".