Daraprim Tablet
NDC Package 69413-330-06

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

Package Information

Daraprim (pyrimethamine) tablets is a medication used with other medication (such as a sulfonamide) to treat a serious parasite infection (toxoplasmosis) of the body, brain, or eye or to prevent toxoplasmosis infection in people with HIV infection. This formulation utilizes a tablet delivery system. Marketed by Vyera Pharmaceuticals Llc, this product is identified by NDC 69413-330 and is authorized under FDA application NDA008578.

Identification & Billing

NDC Package Code
69413-330-06
Package Description
6 TABLET in 1 BOTTLE, PLASTIC
Product Code
69413-330
11-Digit Billing Format
69413033006
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Daraprim
Non-Proprietary Name
Pyrimethamine
Substance Name
Pyrimethamine
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PYRIMETHAMINE 25 mg/1
Pharmacologic Class
Usage Information
This medication is used with other medication (such as a sulfonamide) to treat a serious parasite infection (toxoplasmosis) of the body, brain, or eye or to prevent toxoplasmosis infection in people with HIV infection. Pyrimethamine belongs to a class of drugs known as antiparasitics. It works by killing parasites.

Regulatory & Marketing

Labeler Name
Vyera Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
NDA008578
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-23-1953
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (69413-330). Click a package code to view its specific billing and regulatory data.

69413-330-10
100 TABLET in 1 BOTTLE, PLASTIC
69413-330-30
30 TABLET in 1 BOTTLE, PLASTIC

* 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 69413-330-06 identifies a specific commercial package of 6 tablet in 1 bottle, plastic of Daraprim, a human prescription drug labeled by Vyera Pharmaceuticals Llc. This tablet is formulated for oral use and contains pyrimethamine 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 Vyera Pharmaceuticals Llc on January 23, 1953. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used with other medication (such as a sulfonamide) to treat a serious parasite infection (toxoplasmosis) of the body, brain, or eye or to prevent toxoplasmosis infection in people with HIV infection. Pyrimethamine belongs to a class of drugs known as antiparasitics. It works by killing parasites.

How is this Vyera Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69413033006. 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)
69413-330-06
11-Digit CMS (5-4-2)
69413-0330-06

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