Amantadine Hydrochloride Tablet
NDC Package 71765-009-01

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

Package Information

Amantadine Hydrochloride tablets are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. This formulation utilizes a tablet delivery system. Marketed by Zhejiang Jutai Pharmaceutical Co., Ltd., this product is identified by NDC 71765-009 and is authorized under FDA application ANDA218598.

Identification & Billing

NDC Package Code
71765-009-01
Package Description
2 BLISTER PACK in 1 BOX / 12 TABLET in 1 BLISTER PACK
Product Code
71765-009
11-Digit Billing Format
71765000901
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Amantadine Hydrochloride
Non-Proprietary Name
Amantadine Hydrochloride
Substance Name
Amantadine Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
AMANTADINE HYDROCHLORIDE 100 mg/1
Pharmacologic Class
Usage Information
Amantadine hydrochloride tablets are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride tablets are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.

Regulatory & Marketing

Labeler Name
Zhejiang Jutai Pharmaceutical Co., Ltd.
Product Type
Human Prescription Drug
FDA Application #
ANDA218598
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-26-2024
Listing Expiration
12-31-2027
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 71765-009-01 identifies a specific commercial package of 2 blister pack in 1 box / 12 tablet in 1 blister pack of Amantadine Hydrochloride, a human prescription drug labeled by Zhejiang Jutai Pharmaceutical Co., Ltd.. This tablet 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 Zhejiang Jutai Pharmaceutical Co., Ltd. on September 26, 2024. The current certification is valid through December 31, 2027.

How is this Zhejiang Jutai Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71765000901. 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)
71765-009-01
11-Digit CMS (5-4-2)
71765-0009-01

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