Alprazolam Tablet, Extended Release
NDC Package 65162-809-06

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

Alprazolam tablets is alprazolam is used to treat anxiety and panic disorders. This formulation utilizes a tablet, extended release delivery system. Marketed by Amneal Pharmaceuticals Llc, this product is identified by NDC 65162-809 and is authorized under FDA application ANDA078387.

Identification & Billing

NDC Package Code
65162-809-06
Package Description
60 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
65162-809
11-Digit Billing Format
65162080906
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk
  • RxCUI: 433798 - ALPRAZolam 0.5 MG 24HR Extended Release Oral Tablet
  • RxCUI: 433798 - 24 HR alprazolam 0.5 MG Extended Release Oral Tablet
  • RxCUI: 433798 - alprazolam 0.5 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 433799 - ALPRAZolam 2 MG 24HR Extended Release Oral Tablet
  • RxCUI: 433799 - 24 HR alprazolam 2 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Alprazolam
Non-Proprietary Name
Alprazolam
Substance Name
Alprazolam
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ALPRAZOLAM .5 mg/1
Pharmacologic Class
Usage Information
Alprazolam is used to treat anxiety and panic disorders. It belongs to a class of medications called benzodiazepines which act on the brain and nerves (central nervous system) to produce a calming effect. It works by enhancing the effects of a certain natural chemical in the body (GABA).
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA078387
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-03-2009
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65162-809). Click a package code to view its specific billing and regulatory data.

65162-809-03
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
65162-809-50
500 TABLET, EXTENDED RELEASE 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 65162-809-06 identifies a specific commercial package of 60 tablet, extended release in 1 bottle of Alprazolam, a human prescription drug labeled by Amneal Pharmaceuticals Llc. This tablet, extended release is formulated for oral use and contains alprazolam 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 Amneal Pharmaceuticals Llc on December 03, 2009. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Alprazolam is used to treat anxiety and panic disorders. It belongs to a class of medications called benzodiazepines which act on the brain and nerves (central nervous system) to produce a calming effect. It works by enhancing the effects of a certain natural chemical in the body (GABA).

How is this Amneal Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65162080906. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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 (5-3-2)
65162-809-06
11-Digit CMS (5-4-2)
65162-0809-06

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