Valproate Semisodium Capsule
NDC Package 0074-0805-22

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Valproate Semisodium 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 delivery system. Marketed by Abbvie Inc., this product is identified by NDC 0074-0805.

Identification & Billing

NDC Package Code
0074-0805-22
Package Description
25000 CAPSULE in 1 DRUM
Product Code
0074-0805
11-Digit Billing Format
00074080522

Clinical Specifications

Proprietary Name
Valproate Semisodium
Non-Proprietary Name
Valproate Semisodium
Substance Name
Divalproex Sodium
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Active Ingredient(s)
DIVALPROEX SODIUM 125 mg/1
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
Abbvie Inc.
Product Type
Drug For Further Processing
Marketing Category
EXPORT ONLY - A product that is only exported and not marketed in the United States.
Start Marketing Date
07-22-2015
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 0074-0805-22 identifies a specific commercial package of 25000 capsule in 1 drum of Valproate Semisodium (UNFINISHED drug), drug for further processing labeled by Abbvie Inc.. This capsule is formulated for 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 Abbvie Inc. on July 22, 2015. 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 Abbvie Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00074080522. 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 (4-4-2)
0074-0805-22
11-Digit CMS (5-4-2)
00074-0805-22

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