Divalproex Sodium Capsule, Coated Pellets
NDC Package 17856-0109-1

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

Package Information

Divalproex Sodium capsules 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 capsule, coated pellets delivery system. Marketed by Atlantic Biologicals Corp., this product is identified by NDC 17856-0109 and is authorized under FDA application ANDA078919.

Identification & Billing

NDC Package Code
17856-0109-1
Package Description
100 POUCH in 1 BOX / 1 CAPSULE, COATED PELLETS in 1 POUCH
Product Code
17856-0109
11-Digit Billing Format
17856010901
RxNorm Crosswalk
RxCUI: 1099596 - divalproex sodium 125 MG Delayed Release Oral Capsule

Clinical Specifications

Proprietary Name
Divalproex Sodium
Non-Proprietary Name
Divalproex Sodium
Substance Name
Divalproex Sodium
Dosage Form
Capsule, Coated Pellets - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which varying amounts of coating have been applied.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DIVALPROEX SODIUM 125 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
Atlantic Biologicals Corp.
Product Type
Human Prescription Drug
FDA Application #
ANDA078919
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-31-2019
Listing Expiration
12-31-2026
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 17856-0109-1 identifies a specific commercial package of 100 pouch in 1 box / 1 capsule, coated pellets in 1 pouch of Divalproex Sodium, a human prescription drug labeled by Atlantic Biologicals Corp.. This capsule, coated pellets 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 Atlantic Biologicals Corp. on January 31, 2019. The current certification is valid through December 31, 2026.

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 Atlantic Biologicals Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856010901. 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)
17856-0109-1
11-Digit CMS (5-4-2)
17856-0109-01

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