Amikacin Sulfate Powder
NDC Package 62991-2002-4

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

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Amikacin Sulfate powders is a medication used to prevent or treat a wide variety of bacterial infections. This formulation utilizes a powder delivery system. Marketed by Letco Medical, Llc, this product is identified by NDC 62991-2002.

Identification & Billing

NDC Package Code
62991-2002-4
Package Description
1000 g in 1 JAR
Product Code
62991-2002
11-Digit Billing Format
62991200204
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
1000 GM

Clinical Specifications

Proprietary Name
Amikacin Sulfate
Non-Proprietary Name
Amikacin Sulfate
Substance Name
Amikacin Sulfate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
AMIKACIN SULFATE 1 g/g
Usage Information
This medication is used to prevent or treat a wide variety of bacterial infections. Amikacin belongs to a class of drugs known as aminoglycoside antibiotics. It works by stopping the growth of bacteria.

Regulatory & Marketing

Labeler Name
Letco Medical, Llc
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
11-18-2010
End Marketing Date
08-19-2027
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (62991-2002). Click a package code to view its specific billing and regulatory data.

62991-2002-1
5 g in 1 JAR
62991-2002-2
25 g in 1 JAR

* 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 62991-2002-4 identifies a specific commercial package of 1000 g in 1 jar of Amikacin Sulfate (UNFINISHED drug), a bulk ingredient labeled by Letco Medical, Llc. This product is billed per "GM" gram and contains an estimated amount of 1000 billable units per package. This powder is formulated for use and contains amikacin sulfate 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 Letco Medical, Llc on November 18, 2010.

What are the primary indications for this medication?

This medication is used to prevent or treat a wide variety of bacterial infections. Amikacin belongs to a class of drugs known as aminoglycoside antibiotics. It works by stopping the growth of bacteria.

How is this Letco Medical, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62991200204. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 1000 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 (5-4-1)
62991-2002-4
11-Digit CMS (5-4-2)
62991-2002-04

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