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  5. NDC Package Code: 76045-211-20 Midazolam

NDC Package 76045-211-20 Midazolam

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

Table of Contents

    1. Package Information
    2. 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:
76045-211-20
Package Description:
24 BLISTER PACK in 1 CARTON / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-211-00) / 2 mL in 1 SYRINGE, GLASS
Product Code:
76045-211
Proprietary Name:
Midazolam
Non-Proprietary Name:
Midazolam Hydrochloride
Substance Name:
Midazolam Hydrochloride
Usage Information:
Midazolam injection 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:
76045021120
NDC to RxNorm Crosswalk:
  • RxCUI: 1551393 - midazolam 10 MG in 2 ML Prefilled Syringe
  • RxCUI: 1551393 - 2 ML midazolam 5 MG/ML Prefilled Syringe
  • RxCUI: 1551393 - midazolam (as midazolam hydrochloride) 10 MG per 2 ML Prefilled Syringe
  • RxCUI: 1551395 - midazolam 5 MG in 1 ML Prefilled Syringe
  • RxCUI: 1551395 - 1 ML midazolam 5 MG/ML Prefilled Syringe
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Fresenius Kabi Usa, Llc
    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 2 mg/2mL
    • Pharmacologic Class(es):
  • Benzodiazepine - [EPC] (Established Pharmacologic Class)
  • Benzodiazepines - [CS]
    • DEA Schedule:
    Schedule IV (CIV) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA203460
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-16-2021
    Listing Expiration Date:
    12-31-2025
    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.

    Frequently Asked Questions

    What is NDC 76045-211-20?

    The NDC Packaged Code 76045-211-20 is assigned to a package of 24 blister pack in 1 carton / 1 syringe, glass in 1 blister pack (76045-211-00) / 2 ml in 1 syringe, glass of Midazolam, a human prescription drug labeled by Fresenius Kabi Usa, Llc. The product's dosage form is injection, solution and is administered via intramuscular; intravenous form.

    Is NDC 76045-211 included in the NDC Directory?

    Yes, Midazolam with product code 76045-211 is active and included in the NDC Directory. The product was first marketed by Fresenius Kabi Usa, Llc on April 16, 2021 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 76045-211-20?

    The 11-digit format is 76045021120. 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
    5-3-276045-211-205-4-276045-0211-20