Depakote
NDC Package 43353-310-80

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Depakote is a medication used to treat seizure disorders, certain psychiatric conditions (manic phase of bipolar disorder), and to prevent migraine headaches. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 43353-310 and is authorized under FDA application NDA021168.

Identification & Billing

NDC Package Code
43353-310-80
Package Description
180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
43353-310
11-Digit Billing Format
43353031080
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
180 EA
RxNorm Crosswalk
  • RxCUI: 1099569 - divalproex sodium 500 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1099569 - 24 HR divalproex sodium 500 MG Extended Release Oral Tablet
  • RxCUI: 1099569 - divalproex sodium 500 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 1099571 - Depakote ER 500 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1099571 - 24 HR divalproex sodium 500 MG Extended Release Oral Tablet [Depakote]

Clinical Specifications

Proprietary Name
Depakote ER
Dosage Form
-
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
Aphena Pharma Solutions - Tennessee, Llc
FDA Application #
NDA021168
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-04-2000
Listing Expiration
12-31-2019
Exclude Flag
I
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 (43353-310). Click a package code to view its specific billing and regulatory data.

43353-310-53
60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
43353-310-60
90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
43353-310-70
120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

* 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 43353-310-80 identifies a specific commercial package of 180 tablet, extended release in 1 bottle, plastic of Depakote ER, labeled by Aphena Pharma Solutions - Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 180 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Aphena Pharma Solutions - Tennessee, Llc on August 04, 2000. The current certification is valid through December 31, 2019.

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 Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43353031080. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 180 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)
43353-310-80
11-Digit CMS (5-4-2)
43353-0310-80

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