Midazolam Injection, Solution
NDC Package 42571-415-91
Package Information
Midazolam 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 Micro Labs Limited, this product is identified by NDC 42571-415 and is authorized under FDA application ANDA217504.
Identification & Billing
- RxCUI: 1666798 - midazolam 2 MG in 2 ML Injection
- RxCUI: 1666798 - 2 ML midazolam 1 MG/ML Injection
- RxCUI: 1666798 - midazolam 2 MG per 2 ML Injection
- RxCUI: 1666814 - midazolam 5 MG in 1 ML Injection
- RxCUI: 1666814 - 1 ML midazolam 5 MG/ML Injection
Clinical Specifications
- Intramuscular - Administration within a muscle.
- Intravenous - Administration within or into a vein or veins.
Regulatory & Marketing
Hierarchy Structure
- 42571 - Micro Labs Limited
- 42571-415 - Midazolam
- 42571-415-91 - 10 VIAL in 1 CARTON / 2 mL in 1 VIAL (42571-415-75)
- 42571-415 - Midazolam
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 (42571-415). Click a package code to view its specific billing and regulatory data.
* 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 42571-415-91 identifies a specific commercial package of 10 vial in 1 carton / 2 ml in 1 vial (42571-415-75) of Midazolam, a human prescription drug labeled by Micro Labs Limited. This injection, solution is formulated for intramuscular; 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 Micro Labs Limited on January 01, 2024. The current certification is valid through December 31, 2026.
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 Micro Labs Limited product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 42571041591. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
