Divalproex Sodium Tablet, Film Coated, Extended Release
NDC Package 68084-310-01

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

Package Information

Divalproex Sodium tablets is a medication used to treat seizure disorders, certain psychiatric conditions (manic phase of bipolar disorder), and to prevent migraine headaches. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by American Health Packaging, this product is identified by NDC 68084-310 and is authorized under FDA application ANDA078239.

Identification & Billing

NDC Package Code
68084-310-01
Package Description
100 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-310-11)
Product Code
68084-310
11-Digit Billing Format
68084031001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 1099563 - divalproex sodium 250 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1099563 - 24 HR divalproex sodium 250 MG Extended Release Oral Tablet
  • RxCUI: 1099563 - divalproex sodium 250 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 1099569 - divalproex sodium 500 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1099569 - 24 HR divalproex sodium 500 MG Extended Release Oral Tablet

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
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
American Health Packaging
Product Type
Human Prescription Drug
FDA Application #
ANDA078239
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-21-2013
End Marketing Date
11-30-2026
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 68084-310-01 identifies a specific commercial package of 100 blister pack in 1 box, unit-dose / 1 tablet, film coated, extended release in 1 blister pack (68084-310-11) of Divalproex Sodium, a human prescription drug labeled by American Health Packaging. 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 American Health Packaging on November 21, 2013.

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 American Health Packaging product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68084031001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
68084-310-01
11-Digit CMS (5-4-2)
68084-0310-01

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