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  5. NDC Package Code: 53808-1061-1 Divalproex Sodium Extended-release

NDC Package 53808-1061-1 Divalproex Sodium Extended-release

View Billable Units, 11-Digit Format, RxNorm

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.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
53808-1061-1
Package Description:
30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code:
53808-1061
Proprietary Name:
Divalproex Sodium Extended-release
Usage Information:
Divalproex sodium extended-release tablets should not be administered to patients with hepatic disease or significant hepatic dysfunction [see Warnings and Precautions (5.1)].Divalproex sodium extended-release tablets are contraindicated in patients known to have mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG; e.g., Alpers-Huttenlocher Syndrome) and children under two years of age who are suspected of having a POLG-related disorder [see Warnings and Precautions (5.1)].Divalproex sodium extended-release tablets are contraindicated in patients with known hypersensitivity to the drug [see Warnings and Precautions (5.13)].Divalproex sodium extended-release tablets are contraindicated in patients with known urea cycle disorders [see Warnings and Precautions (5.6)].Divalproex sodium extended-release tablets are contraindicated for use in prophylaxis of migraine headaches in pregnant women [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1)].
11-Digit NDC Billing Format:
53808106101
NDC to 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
    • Labeler Name:
    State Of Florida Doh Central Pharmacy
    Sample Package:
    No
    Start Marketing Date:
    11-01-2014
    Listing Expiration Date:
    12-31-2017
    Exclude Flag:
    I
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 53808-1061-1?

    The NDC Packaged Code 53808-1061-1 is assigned to a package of 30 tablet, extended release in 1 blister pack of Divalproex Sodium Extended-release, labeled by State Of Florida Doh Central Pharmacy. The product's dosage form is and is administered via form.

    Is NDC 53808-1061 included in the NDC Directory?

    No, Divalproex Sodium Extended-release with product code 53808-1061 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by State Of Florida Doh Central Pharmacy on November 01, 2014 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 53808-1061-1?

    The 11-digit format is 53808106101. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-153808-1061-15-4-253808-1061-01