Amantadine Hydrochloride
NDC Package 54868-0800-2
Package Information
Amantadine Hydrochloride is capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-0800 and is authorized under FDA application ANDA071293.
Identification & Billing
- RxCUI: 849389 - amantadine HCl 100 MG Oral Capsule
- RxCUI: 849389 - amantadine hydrochloride 100 MG Oral Capsule
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 54868 - Physicians Total Care, Inc.
- 54868-0800 - Amantadine Hydrochloride
- 54868-0800-2 - 20 CAPSULE in 1 BOTTLE, PLASTIC
- 54868-0800 - Amantadine Hydrochloride
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 (54868-0800). Click a package code to view its specific billing and regulatory data.
* 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 54868-0800-2 identifies a specific commercial package of 20 capsule in 1 bottle, plastic of Amantadine Hydrochloride, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 20 billable units per package. 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 Physicians Total Care, Inc. on January 06, 1993. The current certification is valid through December 31, 2017.
How is this Physicians Total Care, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868080002. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 20 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:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.
