Divalproex Sodiumdelayed-release
NDC Package 33261-621-60

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

Divalproex Sodiumdelayed-release is divalproex sodium should not be administered to patients with hepatic disease or significant hepatic dysfunction [see Warnings and Precautions (5.1)]. Marketed by Aidarex Pharmaceuticals Llc, this product is identified by NDC 33261-621 and is authorized under FDA application ANDA090210.

Identification & Billing

NDC Package Code
33261-621-60
Package Description
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
33261-621
11-Digit Billing Format
33261062160
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk
RxCUI: 1099870 - divalproex sodium 500 MG Delayed Release Oral Tablet

Clinical Specifications

Proprietary Name
Divalproex Sodiumdelayed-release Delayed-release
Dosage Form
-
Usage Information
Divalproex sodium should not be administered to patients with hepatic disease or significant hepatic dysfunction [see Warnings and Precautions (5.1)]. Divalproex sodium is contraindicated in patients with known hypersensitivity to the drug [see Warnings and Precautions (5.12)].Divalproex sodium is contraindicated in patients with known urea cycle disorders [see Warnings and Precautions (5.6)]. Divalproex sodium is contraindicated for use in prophylaxis of migraine headaches in pregnant women [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1)].

Regulatory & Marketing

Labeler Name
Aidarex Pharmaceuticals Llc
FDA Application #
ANDA090210
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-30-2009
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 33261-621-60 identifies a specific commercial package of 60 tablet, film coated in 1 bottle, plastic of Divalproex Sodiumdelayed-release Delayed-release, labeled by Aidarex Pharmaceuticals Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 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 Aidarex Pharmaceuticals Llc on November 30, 2009. The current certification is valid through December 31, 2019.

How is this Aidarex Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33261062160. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
33261-621-60
11-Digit CMS (5-4-2)
33261-0621-60

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