Primaquine Phosphate Powder
NDC 42973-177
View dosage, usage, ingredients, routes, and UNII mappings.
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.
Primaquine Phosphate is a BULK INGREDIENT-approved product labeled by Apicore Pharmaceuticals Private Limited. Primaquine is used with other medications to prevent and treat malaria caused by mosquito bites in countries where malaria is common. It is supplied as a powder. This product entry covers the primary NDC 42973-177 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
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
Code Navigator:
Clinical Specifications
Dosage Form:
Powder
- An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
42973
Marketing Category: [8]
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Marketing Timeline
Start Marketing Date: [9]
09-01-2013
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Unfinished Product: [13]
Yes
Code Structure Chart
Product Details
What is NDC 42973-177?
The NDC code 42973-177 is assigned by the FDA to the product Primaquine Phosphate. It is commonly known by its generic name, primaquine phosphate. This pharmaceutical product is labeled by Apicore Pharmaceuticals Private Limited and is currently categorized as listed product. The medication is a powder. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 42973-177-00. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
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 Active Ingredients of this product?
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 & Regulatory Definitions
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.
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.
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.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
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.
