Divalproex Sodium
NDC Package 48433-126-10

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.

Divalproex Sodium is a medication used to treat seizure disorders, certain psychiatric conditions (manic phase of bipolar disorder), and to prevent migraine headaches. Marketed by Safecor Health, Llc, this product is identified by NDC 48433-126 and is authorized under FDA application ANDA090161.

Identification & Billing

NDC Package Code
48433-126-10
Package Description
100 BLISTER PACK in 1 BOX / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (48433-126-01)
Product Code
48433-126
11-Digit Billing Format
48433012610

Clinical Specifications

Proprietary Name
Divalproex Sodium
Dosage Form
-
Usage Information
This medication is used to treat seizure disorders, certain psychiatric conditions (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
Safecor Health, Llc
FDA Application #
ANDA090161
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-11-2013
End Marketing Date
09-01-2022
Listing Expiration
09-01-2022
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 48433-126-10 identifies a specific commercial package of 100 blister pack in 1 box / 1 tablet, extended release in 1 blister pack (48433-126-01) of Divalproex Sodium, labeled by Safecor Health, Llc. 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 Safecor Health, Llc on August 11, 2013. The current certification is valid through September 01, 2022.

What are the primary indications for this medication?

This medication is used to treat seizure disorders, certain psychiatric conditions (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 Safecor Health, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 48433012610. 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)
48433-126-10
11-Digit CMS (5-4-2)
48433-0126-10

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