L-glutamine Powder, For Solution
NDC Package 70954-417-20

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

Package Information

L-glutamine powders is l-glutamine is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older. This formulation utilizes a powder, for solution delivery system. Marketed by Ani Pharmaceuticals, Inc., this product is identified by NDC 70954-417 and is authorized under FDA application ANDA215647.

Identification & Billing

NDC Package Code
70954-417-20
Package Description
60 PACKET in 1 CARTON / 1 POWDER, FOR SOLUTION in 1 PACKET (70954-417-10)
Product Code
70954-417
11-Digit Billing Format
70954041720
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
L-glutamine
Non-Proprietary Name
L-glutamine
Substance Name
Glutamine
Dosage Form
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
GLUTAMINE 5 g/1
Pharmacologic Class
Usage Information
L-glutamine is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older.

Regulatory & Marketing

Labeler Name
Ani Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA215647
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-11-2024
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70954-417-20 identifies a specific commercial package of 60 packet in 1 carton / 1 powder, for solution in 1 packet (70954-417-10) of L-glutamine, a human prescription drug labeled by Ani Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This powder, for solution is formulated for oral use and contains glutamine 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 Ani Pharmaceuticals, Inc. on July 11, 2024. The current certification is valid through December 31, 2026.

How is this Ani Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70954041720. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
70954-417-20
11-Digit CMS (5-4-2)
70954-0417-20

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