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  4. NDC Product Code: 64725-0315 Divalproex Sodium Extended-release

NDC 64725-0315 Divalproex Sodium Extended-release

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 64725-0315?
  5. Divalproex Sodium Extended-release Uses
  6. Active Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

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

Get all the details for National Drug Code (NDC) 64725-0315 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
64725-0315
Proprietary Name:
Divalproex Sodium Extended-release
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Tya Pharmaceuticals
Labeler Code:
64725
Product Label ID:
49a585a8-327a-44b2-b45b-7a0959724dc6
FDA Application Number: [6]
NDA021168
Marketing Category: [8]
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date: [9]
08-12-2013
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
GRAY (C48324)
Shape:
OVAL (C48345)
Size(s):
17 MM
19 MM
Imprint(s):
A;HF
A;HC
Score:
1

Code Structure Chart

Product Details

What is NDC 64725-0315?

The NDC code 64725-0315 is assigned by the FDA to the product Divalproex Sodium Extended-release which is product labeled by Tya Pharmaceuticals. The product's dosage form is . The product is distributed in a single package with assigned NDC code 64725-0315-1 15 tablet, extended release in 1 container . 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 and Use in Specific Populations ] (5.3)(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: 1099563 - divalproex sodium 250 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1099563 - 24 HR divalproex sodium 250 MG Extended Release Oral Tablet
  • RxCUI: 1099563 - divalproex sodium 250 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 1099569 - divalproex sodium 500 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1099569 - 24 HR divalproex sodium 500 MG 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.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".