Chloroquine Phosphate Tablet
NDC Package 0115-7010-01

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

Chloroquine Phosphate tablets is chloroquine is used to prevent or treat malaria caused by mosquito bites. This formulation utilizes a tablet delivery system. Marketed by Amneal Pharmaceuticals Of New York Llc, this product is identified by NDC 0115-7010 and is authorized under FDA application ANDA040516.

Identification & Billing

NDC Package Code
0115-7010-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
0115-7010
11-Digit Billing Format
00115701001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Chloroquine Phosphate
Non-Proprietary Name
Chloroquine Phosphate
Substance Name
Chloroquine Phosphate
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)
CHLOROQUINE PHOSPHATE 500 mg/1
Pharmacologic Class
Antimalarial - [EPC] (Established Pharmacologic Class)
Usage Information
Chloroquine is used to prevent or treat malaria caused by mosquito bites. Chloroquine 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. Chloroquine is also used to treat infection caused by a different type of parasite (ameba). Chloroquine is not recommended for coronavirus infection, also known as COVID-19, unless you are enrolled in a study. Talk to your doctor about the risks and benefits.

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Of New York Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA040516
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-10-2022
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 (0115-7010). Click a package code to view its specific billing and regulatory data.

0115-7010-02
500 TABLET in 1 BOTTLE
0115-7010-09
25 TABLET in 1 BOTTLE

* 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 0115-7010-01 identifies a specific commercial package of 100 tablet in 1 bottle of Chloroquine Phosphate, a human prescription drug labeled by Amneal Pharmaceuticals Of New York Llc. This tablet is formulated for oral use and contains chloroquine 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 Amneal Pharmaceuticals Of New York Llc on May 10, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Chloroquine is used to prevent or treat malaria caused by mosquito bites. Chloroquine 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. Chloroquine is also used to treat infection caused by a different type of parasite (ameba). Chloroquine is not recommended for coronavirus infection, also known as COVID-19, unless you are enrolled in a study. Talk to your doctor about the risks and benefits.

How is this Amneal Pharmaceuticals Of New York Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00115701001. 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 (4-4-2)
0115-7010-01
11-Digit CMS (5-4-2)
00115-7010-01

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