Divalproex Sodium
NDC Package 21695-817-60

11-digit billing NDC: 21695081760 · Billing unit: EA · 60 EA per package
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 Sodium is maniaDivalproex sodium delayed-release tablets are indicated for the treatment of the manic episodes associated with bipolar disorder. Marketed by Rebel Distributors Corp, this product is identified by NDC 21695-817 and is authorized under FDA application ANDA078790.

Identification & Billing

NDC Package Code
21695-817-60
Package Description
60 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code
21695-817
11-Digit Billing Format
21695081760
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Divalproex Sodium DR
Dosage Form
-
Usage Information
ManiaDivalproex sodium delayed-release tablets are indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgement, aggressiveness, and possible hostility.The efficacy of divalproex sodium delayed-release tablets was established in 3-week trials with patients meeting DSMIII-R criteria for bipolar disorder who were hospitalized for acute mania (See Clinical Trials under CLINICAL PHARMACOLOGY ).The safety and effectiveness of divalproex sodium delayed-release tablets for long-term use in mania, i.e., more than 3 weeks, has not been systematically evaluated in controlled clinical trials. Therefore, physicians who elect to use divalproex sodium delayed-release tablets for extended periods should continually reevaluate the long-term usefulness of the drug for the individual patient.EpilepsyDivalproex sodium delayed-release tablets are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex sodium delayed-release tablets are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures. Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.MigraineDivalproex sodium delayed-release tablets are indicated for prophylaxis of migraine headaches. There is no evidence that Divalproex sodium delayed-release tablets are useful in the acute treatment of migraine headaches. Because valproic acid may be a hazard to the fetus, divalproex sodium delayed-release tablets should be considered for women of childbearing potential only after this risk has been thoroughly discussed with the patient and weighed against the potential benefits of treatment (see WARNINGS - Usage In Pregnancy, PRECAUTIONS - Information for Patients).SEE WARNINGS  FOR STATEMENT REGARDING FATAL HEPATIC DYSFUNCTION.

Regulatory & Marketing

Labeler Name
Rebel Distributors Corp
FDA Application #
ANDA078790
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-14-2009
Listing Expiration
12-31-2017
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 21695-817-60 identifies a specific commercial package of 60 tablet, delayed release in 1 bottle of Divalproex Sodium DR, labeled by Rebel Distributors Corp. 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 Rebel Distributors Corp on October 14, 2009. The current certification is valid through December 31, 2017.

How is this Rebel Distributors Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21695081760. 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)
21695-817-60
11-Digit CMS (5-4-2)
21695-0817-60

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