Meropenem Injection
NDC Package 72485-412-01

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

Package Information

Meropenem injection is meropenem is used to treat a wide variety of bacterial infections. This formulation utilizes a injection delivery system. Marketed by Armas Pharmaceuticals Inc, this product is identified by NDC 72485-412 and is authorized under FDA application ANDA216154.

Identification & Billing

NDC Package Code
72485-412-01
Package Description
1 VIAL in 1 CARTON / 20 mL in 1 VIAL
Product Code
72485-412
11-Digit Billing Format
72485041201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Meropenem
Non-Proprietary Name
Meropenem
Substance Name
Meropenem
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)
MEROPENEM 1 g/20mL
Pharmacologic Class
Usage Information
Meropenem is used to treat a wide variety of bacterial infections. This medication is known as a carbapenem-type antibiotic. It works by stopping the growth of bacteria.

Regulatory & Marketing

Labeler Name
Armas Pharmaceuticals Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA216154
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-31-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (72485-412). Click a package code to view its specific billing and regulatory data.

72485-412-10
10 VIAL in 1 CARTON / 20 mL in 1 VIAL
72485-412-25
25 VIAL in 1 CARTON / 20 mL in 1 VIAL

* 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 72485-412-01 identifies a specific commercial package of 1 vial in 1 carton / 20 ml in 1 vial of Meropenem, a human prescription drug labeled by Armas Pharmaceuticals Inc. This injection is formulated for intravenous use and contains meropenem 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 Armas Pharmaceuticals Inc on May 31, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Meropenem is used to treat a wide variety of bacterial infections. This medication is known as a carbapenem-type antibiotic. It works by stopping the growth of bacteria.

How is this Armas Pharmaceuticals Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72485041201. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
72485-412-01
11-Digit CMS (5-4-2)
72485-0412-01

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