Midazolam
NDC Package 82449-203-02

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Midazolam is injectable midazolam hydrochloride 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 Steriscience Specialties Private Limited, this product is identified by NDC 82449-203 and is authorized under FDA application ANDA090315.

Identification & Billing

NDC Package Code
82449-203-02
Package Description
10 VIAL in 1 CARTON / 2 mL in 1 VIAL
Product Code
82449-203
11-Digit Billing Format
82449020302

Clinical Specifications

Proprietary Name
Midazolam
Dosage Form
-
Usage Information
Injectable midazolam hydrochloride 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.

Regulatory & Marketing

Labeler Name
Steriscience Specialties Private Limited
FDA Application #
ANDA090315
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-31-2023
End Marketing Date
01-30-2026
Listing Expiration
01-30-2026
Exclude Flag
D
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 82449-203-02 identifies a specific commercial package of 10 vial in 1 carton / 2 ml in 1 vial of Midazolam, labeled by Steriscience Specialties Private 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 Steriscience Specialties Private Limited on July 31, 2023. The current certification is valid through January 30, 2026.

How is this Steriscience Specialties Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82449020302. 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)
82449-203-02
11-Digit CMS (5-4-2)
82449-0203-02

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