Divalproex Sodium Tablet, Delayed Release
NDC Package 69452-433-30

11-digit billing NDC: 69452043330 · Billing unit: EA · 500 EA per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Divalproex Sodium tablets is divalproex sodium is 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. This formulation utilizes a tablet, delayed release delivery system. Marketed by Bionpharma Inc., this product is identified by NDC 69452-433 and is authorized under FDA application ANDA078853.

Identification & Billing

NDC Package Code
69452-433-30
Package Description
500 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code
69452-433
11-Digit Billing Format
69452043330
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
500 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Divalproex Sodium
Non-Proprietary Name
Divalproex Sodium
Substance Name
Divalproex Sodium
Dosage Form
Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DIVALPROEX SODIUM 125 mg/1
Pharmacologic Class
Usage Information
Divalproex sodium is 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
Bionpharma Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA078853
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-26-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (69452-433). Click a package code to view its specific billing and regulatory data.

69452-433-13
30 TABLET, DELAYED RELEASE in 1 BOTTLE
69452-433-20
100 TABLET, DELAYED RELEASE 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 69452-433-30 identifies a specific commercial package of 500 tablet, delayed release in 1 bottle of Divalproex Sodium, a human prescription drug labeled by Bionpharma Inc.. This tablet, delayed 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 Bionpharma Inc. on June 26, 2024. The current certification is valid through December 31, 2027.

How is this Bionpharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69452043330. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 500 total billable units per package. 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)
69452-433-30
11-Digit CMS (5-4-2)
69452-0433-30

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