Amantadine Hydrochloride Capsule, Gelatin Coated
NDC Package 0832-1015-00

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

Package Information

Amantadine Hydrochloride capsules 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 capsule, gelatin coated delivery system. Marketed by Upsher-smith Laboratories, Llc, this product is identified by NDC 0832-1015 and is authorized under FDA application ANDA070589.

Identification & Billing

NDC Package Code
0832-1015-00
Package Description
100 CAPSULE, GELATIN COATED in 1 BOTTLE
Product Code
0832-1015
11-Digit Billing Format
00832101500
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Amantadine Hydrochloride
Non-Proprietary Name
Amantadine Hydrochloride
Substance Name
Amantadine Hydrochloride
Dosage Form
Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
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 capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.

Regulatory & Marketing

Labeler Name
Upsher-smith Laboratories, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA070589
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-15-2011
End Marketing Date
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0832-1015). Click a package code to view its specific billing and regulatory data.

0832-1015-50
500 CAPSULE, GELATIN COATED in 1 BOTTLE

* 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 0832-1015-00 identifies a specific commercial package of 100 capsule, gelatin coated in 1 bottle of Amantadine Hydrochloride, a human prescription drug labeled by Upsher-smith Laboratories, Llc. This capsule, gelatin coated 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 Upsher-smith Laboratories, Llc on September 15, 2011.

How is this Upsher-smith Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00832101500. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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:

10-Digit Format (4-4-2)
0832-1015-00
11-Digit CMS (5-4-2)
00832-1015-00

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