Amantadine Hydrochloride Solution
NDC Package 61037-484-03

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

Package Information

Amantadine Hydrochloride solution is 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. This formulation utilizes a solution delivery system. Marketed by Bajaj Medical, Llc, this product is identified by NDC 61037-484 and is authorized under FDA application ANDA075819.

Identification & Billing

NDC Package Code
61037-484-03
Package Description
473 mL in 1 BOTTLE
Product Code
61037-484
11-Digit Billing Format
61037048403
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
Non-Proprietary Name
Amantadine Hydrochloride
Substance Name
Amantadine Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
AMANTADINE HYDROCHLORIDE 50 mg/5mL
Pharmacologic Class
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
Bajaj Medical, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA075819
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-31-2025
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 61037-484-03 identifies a specific commercial package of 473 ml in 1 bottle of Amantadine Hydrochloride, a human prescription drug labeled by Bajaj Medical, Llc. This solution is formulated for oral use and contains amantadine hydrochloride 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 Bajaj Medical, Llc on July 31, 2025. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61037048403. 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)
61037-484-03
11-Digit CMS (5-4-2)
61037-0484-03

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