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  5. NDC Package Code: 68083-108-01 Midazolam Hydrochloride

NDC Package 68083-108-01 Midazolam Hydrochloride

Injection, Solution Intramuscular; Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
68083-108-01
Package Description:
10 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE
Product Code:
68083-108
Proprietary Name:
Midazolam Hydrochloride
Non-Proprietary Name:
Midazolam Hydrochloride
Substance Name:
Midazolam Hydrochloride
Usage Information:
Midazolam Injection, USP is indicated:intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants;intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia);continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.
11-Digit NDC Billing Format:
68083010801
NDC to RxNorm Crosswalk:
  • RxCUI: 311702 - midazolam 5 MG/ML Injectable Solution
  • RxCUI: 311702 - midazolam (as midazolam hydrochloride) 5 MG/ML Injectable Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Gland Pharma Limited
    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):
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • MIDAZOLAM HYDROCHLORIDE 5 mg/mL
    • Pharmacologic Class(es):
  • Benzodiazepine - [EPC] (Established Pharmacologic Class)
  • Benzodiazepines - [CS]
    • DEA Schedule:
    Schedule IV (CIV) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA090850
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-01-2012
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    68083-108-0210 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68083-108-01?

    The NDC Packaged Code 68083-108-01 is assigned to a package of 10 vial, multi-dose in 1 carton / 5 ml in 1 vial, multi-dose of Midazolam Hydrochloride, a human prescription drug labeled by Gland Pharma Limited. The product's dosage form is injection, solution and is administered via intramuscular; intravenous form.

    Is NDC 68083-108 included in the NDC Directory?

    Yes, Midazolam Hydrochloride with product code 68083-108 is active and included in the NDC Directory. The product was first marketed by Gland Pharma Limited on June 01, 2012 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 68083-108-01?

    The 11-digit format is 68083010801. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-268083-108-015-4-268083-0108-01