Midazolam Hydrochloride
NDC Package 55648-765-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Midazolam Hydrochloride is 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. Marketed by Wockhardt Limited, this product is identified by NDC 55648-765 and is authorized under FDA application ANDA078511.

Identification & Billing

NDC Package Code
55648-765-01
Package Description
10 VIAL in 1 CARTON / 1 mL in 1 VIAL (55648-765-05)
Product Code
55648-765
11-Digit Billing Format
55648076501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Midazolam Hydrochloride
Dosage Form
-
Usage Information
Midazolam hydrochloride 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.Midazolam is associated with a high incidence of partial or complete impairment of recall for the next several hours (see CLINICAL PHARMACOLOGY).

Regulatory & Marketing

Labeler Name
Wockhardt Limited
FDA Application #
ANDA078511
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-10-2008
Listing Expiration
12-31-2019
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (55648-765). Click a package code to view its specific billing and regulatory data.

55648-765-02
10 VIAL in 1 CARTON / 2 mL in 1 VIAL (55648-765-06)
55648-765-03
25 VIAL in 1 CARTON / 1 mL in 1 VIAL (55648-765-05)
55648-765-04
25 VIAL in 1 CARTON / 2 mL in 1 VIAL (55648-765-06)

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 55648-765-01 identifies a specific commercial package of 10 vial in 1 carton / 1 ml in 1 vial (55648-765-05) of Midazolam Hydrochloride, labeled by Wockhardt Limited. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Wockhardt Limited on November 10, 2008. The current certification is valid through December 31, 2019.

How is this Wockhardt Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55648076501. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
55648-765-01
11-Digit CMS (5-4-2)
55648-0765-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.