Pramipexole
NDC Package 57664-005-08

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Pramipexole is a . Marketed by Caraco Pharmaceutical Laboratories, Ltd., this product is identified by NDC 57664-005 and is authorized under FDA application ANDA091683.

Identification & Billing

NDC Package Code
57664-005-08
Package Description
100 TABLET in 1 BOTTLE
Product Code
57664-005
11-Digit Billing Format
57664000508

Clinical Specifications

Proprietary Name
Pramipexole
Dosage Form
-

Regulatory & Marketing

Labeler Name
Caraco Pharmaceutical Laboratories, Ltd.
FDA Application #
ANDA091683
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-23-2013
End Marketing Date
12-28-2018
Listing Expiration
12-28-2018
Exclude Flag
D
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 (57664-005). Click a package code to view its specific billing and regulatory data.

57664-005-13
500 TABLET in 1 BOTTLE
57664-005-18
1000 TABLET in 1 BOTTLE
57664-005-83
30 TABLET in 1 BOTTLE
57664-005-88
100 TABLET 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 57664-005-08 identifies a specific commercial package of 100 tablet in 1 bottle of Pramipexole, labeled by Caraco Pharmaceutical Laboratories, Ltd.. 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 Caraco Pharmaceutical Laboratories, Ltd. on May 23, 2013. The current certification is valid through December 28, 2018.

How is this Caraco Pharmaceutical Laboratories, Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57664000508. 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)
57664-005-08
11-Digit CMS (5-4-2)
57664-0005-08

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