Amantadine Hydrochloride
NDC Package 50436-0646-1

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 oral solution USP is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Marketed by Unit Dose Services, this product is identified by NDC 50436-0646 and is authorized under FDA application ANDA074509.

Identification & Billing

NDC Package Code
50436-0646-1
Package Description
72 CUP, UNIT-DOSE in 1 CASE / 5 mL in 1 CUP, UNIT-DOSE
Product Code
50436-0646
11-Digit Billing Format
50436064601
RxNorm Crosswalk
  • RxCUI: 849385 - amantadine HCl 50 MG in 5 mL Oral Solution
  • RxCUI: 849385 - amantadine hydrochloride 10 MG/ML Oral Solution
  • RxCUI: 849385 - amantadine hydrochloride 100 MG per 10 ML Oral Solution
  • RxCUI: 849385 - amantadine hydrochloride 50 MG per 5 ML Oral Solution

Clinical Specifications

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

Regulatory & Marketing

Labeler Name
Unit Dose Services
FDA Application #
ANDA074509
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-17-1995
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 50436-0646-1 identifies a specific commercial package of 72 cup, unit-dose in 1 case / 5 ml in 1 cup, unit-dose of Amantadine Hydrochloride, labeled by Unit Dose Services. 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 Unit Dose Services on July 17, 1995. The current certification is valid through December 31, 2020.

How is this Unit Dose Services product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50436064601. 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)
50436-0646-1
11-Digit CMS (5-4-2)
50436-0646-01

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