NDC 42973-177 Primaquine Phosphate

Powder - View Dosage, Usage, Ingredients, Routes, UNII

Product Information
Product Packages
What is NDC 42973-177?
Primaquine Phosphate Uses
Active Ingredients

Product Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

NDC Product Code:

42973-177

Proprietary Name:

Primaquine Phosphate

Non-Proprietary Name: [1]

Primaquine Phosphate

Substance Name: [2]

Primaquine Phosphate

NDC Directory Status:

Bulk Ingredient

Product Type: [3]

UNFINISHED PRODUCT INCLUDED in the NDC Directory

Dosage Form:

Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

Labeler Name: [5]

Apicore Pharmaceuticals Private Limited

Labeler Code:

42973

Marketing Category: [8]

BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.

Start Marketing Date: [9]

09-01-2013

Listing Expiration Date: [11]

12-31-2024

Exclude Flag: [12]

Unfinished Product: [13]

Yes

Code Navigator:

Code Structure Chart

Product Details

What is NDC 42973-177?

The NDC code 42973-177 is assigned by the FDA to the UNFINISHED product Primaquine Phosphate which is a bulk ingredient product labeled by Apicore Pharmaceuticals Private Limited. The generic name of Primaquine Phosphate is primaquine phosphate. The product's dosage form is powder. The product is distributed in a single package with assigned NDC code 42973-177-00 50 kg in 1 drum . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Primaquine Phosphate?

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.

What are Primaquine Phosphate Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

PRIMAQUINE PHOSPHATE 1 kg/kg - An aminoquinoline that is given by mouth to produce a radical cure and prevent relapse of vivax and ovale malarias following treatment with a blood schizontocide. It has also been used to prevent transmission of falciparum malaria by those returning to areas where there is a potential for re-introduction of malaria. Adverse effects include anemias and GI disturbances. (From Martindale, The Extra Pharmacopeia, 30th ed, p404)

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Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

[13] What is an Unfinished Product? - This field indicates if the product is an unfinished drug. An unfinished drug is an active pharmaceutical ingredient either alone or with other ingredients that is not a finished drug product. Unfinished drugs are used to process other drugs or for drug compounding.

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