NDC 53808-1061 Divalproex Sodium Extended-release

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
53808-1061
Proprietary Name:
Divalproex Sodium Extended-release
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
State Of Florida Doh Central Pharmacy
Labeler Code:
53808
Start Marketing Date: [9]
11-01-2014
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
GRAY (C48324)
Shape:
OVAL (C48345)
Size(s):
19 MM
Imprint(s):
A;HC
Score:
1

Product Packages

NDC Code 53808-1061-1

Package Description: 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Product Details

What is NDC 53808-1061?

The NDC code 53808-1061 is assigned by the FDA to the product Divalproex Sodium Extended-release which is product labeled by State Of Florida Doh Central Pharmacy. The product's dosage form is . The product is distributed in a single package with assigned NDC code 53808-1061-1 30 tablet, extended release in 1 blister pack . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Divalproex Sodium Extended-release?

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)].

Which are Divalproex Sodium Extended-release UNII Codes?

The UNII codes for the active ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Divalproex Sodium Extended-release?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".