Midazolam In Sodium Chloride Injection
NDC Package 0143-9380-10

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

Package Information

Midazolam In Sodium Chloride injection is indicated:Continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting. This formulation utilizes a injection delivery system. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0143-9380 and is authorized under FDA application ANDA216159.

Identification & Billing

NDC Package Code
0143-9380-10
Package Description
10 POUCH in 1 CARTON / 1 BAG in 1 POUCH (0143-9380-01) / 100 mL in 1 BAG
Product Code
0143-9380
11-Digit Billing Format
00143938010
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Midazolam In Sodium Chloride
Non-Proprietary Name
Midazolam In Sodium Chloride
Substance Name
Midazolam Hydrochloride
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
MIDAZOLAM HYDROCHLORIDE 1 mg/mL
Pharmacologic Class
Usage Information
Midazolam in sodium chloride injection is indicated:Continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Hikma Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA216159
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-19-2023
Listing Expiration
12-31-2026
Exclude Flag
N
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 0143-9380-10 identifies a specific commercial package of 10 pouch in 1 carton / 1 bag in 1 pouch (0143-9380-01) / 100 ml in 1 bag of Midazolam In Sodium Chloride, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. This injection is formulated for intravenous use and contains midazolam hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Hikma Pharmaceuticals Usa Inc. on May 19, 2023. The current certification is valid through December 31, 2026.

How is this Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00143938010. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (4-4-2)
0143-9380-10
11-Digit CMS (5-4-2)
00143-9380-10

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