Valproic
NDC Package 17856-4012-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Valproic is acid should not be administered to patients with hepatic disease or significant hepatic dysfunction [see Warnings and Precautions (5.1)]. Marketed by Atlantic Biologicals Corp., this product is identified by NDC 17856-4012 and is authorized under FDA application ANDA073229.

Identification & Billing

NDC Package Code
17856-4012-1
Package Description
100 POUCH in 1 BOX, UNIT-DOSE / 1 CAPSULE, LIQUID FILLED in 1 POUCH
Product Code
17856-4012
11-Digit Billing Format
17856401201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Valproic
Dosage Form
-
Usage Information
Valproic Acid should not be administered to patients with hepatic disease or significant hepatic dysfunction [see Warnings and Precautions (5.1)]. Valproic Acid 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)].Valproic Acid is contraindicated in patients with known hypersensitivity to the drug [see Warnings and Precautions (5.12)]. Valproic Acid is contraindicated in patients with known urea cycle disorders [see Warnings and Precautions (5.6)].For use in prophylaxis of migraine headaches: Valproic Acid is contraindicated in women who are pregnant and in women of childbearing potential who are not using effective contraception[see Warning and Precautions (5.2, 5.3, 5.4) and Use in Specific Populations (8.1)].

Regulatory & Marketing

Labeler Name
Atlantic Biologicals Corp.
FDA Application #
ANDA073229
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-08-2009
Listing Expiration
12-31-2021
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 17856-4012-1 identifies a specific commercial package of 100 pouch in 1 box, unit-dose / 1 capsule, liquid filled in 1 pouch of Valproic, labeled by Atlantic Biologicals Corp.. 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 Atlantic Biologicals Corp. on September 08, 2009. The current certification is valid through December 31, 2021.

How is this Atlantic Biologicals Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856401201. 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 (5-4-1)
17856-4012-1
11-Digit CMS (5-4-2)
17856-4012-01

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