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  5. NDC Package Code: 68083-618-10 Midazolam In Sodium Chloride

NDC Package 68083-618-10 Midazolam In Sodium Chloride

Injection, Solution 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:
68083-618-10
Package Description:
10 POUCH in 1 CARTON / 1 BAG in 1 POUCH / 50 mL in 1 BAG
Product Code:
68083-618
Proprietary Name:
Midazolam In Sodium Chloride
Non-Proprietary Name:
Midazolam In Sodium Chloride
Substance Name:
Midazolam Hydrochloride
Usage Information:
Midazolam in 0.9% 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.
11-Digit NDC Billing Format:
68083061810
NDC to RxNorm Crosswalk:
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):
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s):
MIDAZOLAM HYDROCHLORIDE 1 mg/mL
Pharmacologic Class(es):
DEA Schedule:
Schedule IV (CIV) Substances
Sample Package:
No
FDA Application Number:
ANDA218993
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
08-12-2024
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 68083-618-10?

The NDC Packaged Code 68083-618-10 is assigned to a package of 10 pouch in 1 carton / 1 bag in 1 pouch / 50 ml in 1 bag of Midazolam In Sodium Chloride, a human prescription drug labeled by Gland Pharma Limited. The product's dosage form is injection, solution and is administered via intravenous form.

Is NDC 68083-618 included in the NDC Directory?

Yes, Midazolam In Sodium Chloride with product code 68083-618 is active and included in the NDC Directory. The product was first marketed by Gland Pharma Limited on August 12, 2024 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 68083-618-10?

The 11-digit format is 68083061810. 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
5-3-268083-618-105-4-268083-0618-10