Valproate Sodium Injection, Solution
NDC Package 25021-797-05

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Valproate Sodium injection should not be administered to patients with hepatic disease or significant hepatic dysfunction [see Warnings and Precautions (5.1)]. This formulation utilizes a injection, solution delivery system. Marketed by Sagent Pharmaceuticals, this product is identified by NDC 25021-797 and is authorized under FDA application ANDA076295.

Identification & Billing

NDC Package Code
25021-797-05
Package Description
10 VIAL in 1 CARTON / 5 mL in 1 VIAL
Product Code
25021-797
11-Digit Billing Format
25021079705
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Valproate Sodium
Non-Proprietary Name
Valproate Sodium
Substance Name
Valproate Sodium
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
VALPROATE SODIUM 100 mg/mL
Pharmacologic Class
Usage Information
Valproate Sodium Injection should not be administered to patients with hepatic disease or significant hepatic dysfunction [see Warnings and Precautions (5.1)]. Valproate Sodium Injection is 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)]. Valproate Sodium Injection is contraindicated in patients with known hypersensitivity to the drug [see Warnings and Precautions (5.11)]. Valproate Sodium Injection is contraindicated in patients with known urea cycle disorders [see Warnings and Precautions (5.6)]. For use in prophylaxis of migraine headaches: Valproate is contraindicated in women who are pregnant and in women of childbearing potential who are not using effective contraception [see Warnings and Precautions (5.2, 5.3, 5.4) and Use in Specific Populations (8.1)].

Regulatory & Marketing

Labeler Name
Sagent Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
ANDA076295
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-01-2024
Listing Expiration
12-31-2027
Exclude Flag
N
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J3379
Source: ASP
Inj, valproate sod, 5 mg
HCPCS Dosage 5 MG
Units / Pkg 1000

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 25021-797-05 identifies a specific commercial package of 10 vial in 1 carton / 5 ml in 1 vial of Valproate Sodium, a human prescription drug labeled by Sagent Pharmaceuticals. This injection, solution is formulated for intravenous use and contains valproate sodium as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Sagent Pharmaceuticals on December 01, 2024. The current certification is valid through December 31, 2027.

How is this Sagent Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 25021079705. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
25021-797-05
11-Digit CMS (5-4-2)
25021-0797-05

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