Pregabalin
NDC Package 75834-296-05

11-digit billing NDC: 75834029605
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.

Pregabalin is capsules are indicated for:Management of neuropathic pain associated with diabetic peripheral neuropathyManagement of postherpetic neuralgiaAdjunctive therapy for the treatment of partial-onset seizures in patients 4 years of age and olderManagement of fibromyalgiaManagement of neuropathic pain associated with spinal cord injuryAdditional pediatric use information is approved for Pfizer's LYRICA (pregabalin) Capsules. Marketed by Nivagen Pharmaceuticals, Inc., this product is identified by NDC 75834-296 and is authorized under FDA application ANDA212988.

Identification & Billing

NDC Package Code
75834-296-05
Package Description
500 CAPSULE in 1 BOTTLE
Product Code
75834-296
11-Digit Billing Format
75834029605

Clinical Specifications

Proprietary Name
Pregabalin
Dosage Form
-
Usage Information
Pregabalin Capsules are indicated for:Management of neuropathic pain associated with diabetic peripheral neuropathyManagement of postherpetic neuralgiaAdjunctive therapy for the treatment of partial-onset seizures in patients 4 years of age and olderManagement of fibromyalgiaManagement of neuropathic pain associated with spinal cord injuryAdditional pediatric use information is approved for Pfizer's LYRICA (pregabalin) Capsules. However, due to Pfizer's marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Regulatory & Marketing

Labeler Name
Nivagen Pharmaceuticals, Inc.
FDA Application #
ANDA212988
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-14-2022
End Marketing Date
08-27-2026
Listing Expiration
08-27-2026
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 (75834-296). Click a package code to view its specific billing and regulatory data.

75834-296-60
60 CAPSULE in 1 BOTTLE
75834-296-90
90 CAPSULE 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 75834-296-05 identifies a specific commercial package of 500 capsule in 1 bottle of Pregabalin, labeled by Nivagen Pharmaceuticals, Inc.. 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 Nivagen Pharmaceuticals, Inc. on July 14, 2022. The current certification is valid through August 27, 2026.

How is this Nivagen Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75834029605. 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)
75834-296-05
11-Digit CMS (5-4-2)
75834-0296-05

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