Primaquine Phosphate Tablet, Film Coated
NDC Package 42291-510-01

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

Package Information

Primaquine Phosphate tablets is primaquine is used with other medications to prevent and treat malaria caused by mosquito bites in countries where malaria is common. This formulation utilizes a tablet, film coated delivery system. Marketed by Avkare, this product is identified by NDC 42291-510 and is authorized under FDA application ANDA206043.

Identification & Billing

NDC Package Code
42291-510-01
Package Description
100 TABLET, FILM COATED in 1 BOTTLE
Product Code
42291-510
11-Digit Billing Format
42291051001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 904170 - primaquine phosphate 26.3 MG Oral Tablet
  • RxCUI: 904170 - primaquine phosphate 26.3 MG (primaquine 15 MG) Oral Tablet

Clinical Specifications

Proprietary Name
Primaquine Phosphate
Non-Proprietary Name
Primaquine Phosphate
Substance Name
Primaquine Phosphate
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PRIMAQUINE PHOSPHATE 15 mg/1
Pharmacologic Class
Antimalarial - [EPC] (Established Pharmacologic Class)
Usage Information
Primaquine is used with other medications to prevent and treat malaria caused by mosquito bites in countries where malaria is common. Malaria parasites can enter the body through these mosquito bites, and then live in body tissues such as red blood cells or the liver. Primaquine is used after other medications (such as chloroquine) have killed the malaria parasites living inside red blood cells. Primaquine then kills the malaria parasites living in other body tissues. This prevents the return of the infection. Both drugs are needed for a complete cure. Primaquine phosphate belongs to a class of drugs known as antimalarials. The United States Centers for Disease Control provide updated guidelines and travel recommendations for the prevention and treatment of malaria in different parts of the world. Discuss the most recent information with your doctor before traveling to areas where malaria occurs.

Regulatory & Marketing

Labeler Name
Avkare
Product Type
Human Prescription Drug
FDA Application #
ANDA206043
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-21-2019
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42291-510-01 identifies a specific commercial package of 100 tablet, film coated in 1 bottle of Primaquine Phosphate, a human prescription drug labeled by Avkare. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This tablet, film coated is formulated for oral use and contains primaquine phosphate 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 Avkare on February 21, 2019. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Primaquine is used with other medications to prevent and treat malaria caused by mosquito bites in countries where malaria is common. Malaria parasites can enter the body through these mosquito bites, and then live in body tissues such as red blood cells or the liver. Primaquine is used after other medications (such as chloroquine) have killed the malaria parasites living inside red blood cells. Primaquine then kills the malaria parasites living in other body tissues. This prevents the return of the infection. Both drugs are needed for a complete cure. Primaquine phosphate belongs to a class of drugs known as antimalarials. The United States Centers for Disease Control provide updated guidelines and travel recommendations for the prevention and treatment of malaria in different parts of the world. Discuss the most recent information with your doctor before traveling to areas where malaria occurs.

How is this Avkare product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291051001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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)
42291-510-01
11-Digit CMS (5-4-2)
42291-0510-01

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