Amantadine Hydrochloride
NDC Package 69844-026-03

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Amantadine Hydrochloride is capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Marketed by Graviti Pharmaceuticals Private Limited, this product is identified by NDC 69844-026 and is authorized under FDA application ANDA207570.

Identification & Billing

NDC Package Code
69844-026-03
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
69844-026
11-Digit Billing Format
69844002603
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Amantadine Hydrochloride
Dosage Form
-
Usage Information
Amantadine hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.

Regulatory & Marketing

Labeler Name
Graviti Pharmaceuticals Private Limited
FDA Application #
ANDA207570
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-30-2016
Listing Expiration
12-31-2020
Exclude Flag
I
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 69844-026-03 identifies a specific commercial package of 100 capsule in 1 bottle of Amantadine Hydrochloride, labeled by Graviti Pharmaceuticals Private Limited. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Graviti Pharmaceuticals Private Limited on September 30, 2016. The current certification is valid through December 31, 2020.

How is this Graviti Pharmaceuticals Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69844002603. 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)
69844-026-03
11-Digit CMS (5-4-2)
69844-0026-03

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