Divalproex Sodium Tablet, Film Coated, Extended Release
NDC Package 67046-1696-3

11-digit billing NDC: 67046169603
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Divalproex Sodium tablets is divalproex sodium extended-release tablets are contraindicated in patients:with hepatic disease or significant hepatic dysfunction [see Warnings and Precautions ( 5.1)]. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Coupler Llc, this product is identified by NDC 67046-1696 and is authorized under FDA application ANDA214643.

Identification & Billing

NDC Package Code
67046-1696-3
Package Description
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
67046-1696
11-Digit Billing Format
67046169603

Clinical Specifications

Proprietary Name
Divalproex Sodium
Non-Proprietary Name
Divalproex Sodium
Substance Name
Divalproex Sodium
Dosage Form
Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DIVALPROEX SODIUM 250 mg/1
Pharmacologic Class
Usage Information
Divalproex sodium extended-release tablets are contraindicated in patients:with hepatic disease or significant hepatic dysfunction [see Warnings and Precautions ( 5.1)]. known to have mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG; e.g., Alpers-Huttenlocher Syndrome) and children under two years of age who are suspected of having a POLG-related disorder [see Warnings and Precautions ( 5.1)] with known hypersensitivity to divalproex sodium, sodium valproate, or valproic acid. Reactions have included multiorgan hypersensitivity, serious dermatologic reactions, and angioedema [see Warnings and Precautions ( 5.12, 5.13, 5.14)]. with known urea cycle disorders [see Warnings and Precautions ( 5.6)]. being treated for prophylaxis of migraine headaches: who are pregnant or in women of childbearing potential who are not using effective contraception [see Warnings and Precautions ( 5.2, 5.3, 5.4) and Use in Specific Populations ( 8.1)].

Regulatory & Marketing

Labeler Name
Coupler Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA214643
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-08-2026
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 67046-1696-3 identifies a specific commercial package of 30 tablet, film coated, extended release in 1 blister pack of Divalproex Sodium, a human prescription drug labeled by Coupler Llc. This tablet, film coated, extended release is formulated for oral use and contains divalproex sodium 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 Coupler Llc on October 08, 2026. The current certification is valid through December 31, 2027.

How is this Coupler Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67046169603. 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)
67046-1696-3
11-Digit CMS (5-4-2)
67046-1696-03

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