Valproic Acid
NDC Package 60505-0366-1

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

Package Information

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

Valproic Acid is a medication used to treat seizure disorders, mental/mood conditions (such as manic phase of bipolar disorder), and to prevent migraine headaches. Marketed by Apotex Corp, this product is identified by NDC 60505-0366 and is authorized under FDA application ANDA077105.

Identification & Billing

NDC Package Code
60505-0366-1
Package Description
5 mL in 1 BOTTLE
Product Code
60505-0366
11-Digit Billing Format
60505036601

Clinical Specifications

Proprietary Name
Valproic Acid
Dosage Form
-
Usage Information
This medication is used to treat seizure disorders, mental/mood conditions (such as manic phase of bipolar disorder), and to prevent migraine headaches. It works by restoring the balance of certain natural substances (neurotransmitters) in the brain.

Regulatory & Marketing

Labeler Name
Apotex Corp
FDA Application #
ANDA077105
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-29-2005
End Marketing Date
07-30-2005
Listing Expiration
07-30-2005
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 60505-0366-1 identifies a specific commercial package of 5 ml in 1 bottle of Valproic Acid, labeled by Apotex Corp. 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 Apotex Corp on July 29, 2005. The current certification is valid through July 30, 2005.

What are the primary indications for this medication?

This medication is used to treat seizure disorders, mental/mood conditions (such as manic phase of bipolar disorder), and to prevent migraine headaches. It works by restoring the balance of certain natural substances (neurotransmitters) in the brain.

How is this Apotex Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60505036601. 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 (5-4-1)
60505-0366-1
11-Digit CMS (5-4-2)
60505-0366-01

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