N/a Injection, Solution
NDC Package 71053-595-01

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

Package Information

N/a (midazolam injection, 10 mg) injection is a medication used by people with epilepsy to treat a certain type of serious seizure that doesn't stop (seizure clusters). This formulation utilizes a injection, solution delivery system. Marketed by Rafa Laboratories, Ltd., this product is identified by NDC 71053-595 and is authorized under FDA application NDA216359.

Identification & Billing

NDC Package Code
71053-595-01
Package Description
480 CARTON in 1 BOX / 40 SYRINGE in 1 CARTON / .7 mL in 1 SYRINGE
Product Code
71053-595
11-Digit Billing Format
71053059501
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
N/a
Non-Proprietary Name
Midazolam Injection, 10 Mg
Substance Name
Midazolam
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
Intramuscular - Administration within a muscle.
Active Ingredient(s)
MIDAZOLAM 10 mg/.7mL
Pharmacologic Class
Usage Information
This medication is used by people with epilepsy to treat a certain type of serious seizure that doesn't stop (seizure clusters). Midazolam belongs to a class of drugs known as benzodiazepines. It may work by increasing the effect of a certain substance in your body (GABA), which helps calm the brain and nerves.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Rafa Laboratories, Ltd.
Product Type
Human Prescription Drug
FDA Application #
NDA216359
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-08-2022
Listing Expiration
12-31-2027
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 71053-595-01 identifies a specific commercial package of 480 carton in 1 box / 40 syringe in 1 carton / .7 ml in 1 syringe of N/a, a human prescription drug labeled by Rafa Laboratories, Ltd.. This injection, solution is formulated for intramuscular use and contains midazolam 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 Rafa Laboratories, Ltd. on August 08, 2022. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used by people with epilepsy to treat a certain type of serious seizure that doesn't stop (seizure clusters). Midazolam belongs to a class of drugs known as benzodiazepines. It may work by increasing the effect of a certain substance in your body (GABA), which helps calm the brain and nerves.

How is this Rafa Laboratories, Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71053059501. 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 (5-3-2)
71053-595-01
11-Digit CMS (5-4-2)
71053-0595-01

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