Chloroquine Phosphate
NDC 23155-850
View NDC Profile Indications and UNII Mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
Chloroquine Phosphate is a ANDA-approved product labeled by Avet Pharmaceuticals Inc.. Chloroquine is used to prevent or treat malaria caused by mosquito bites. It is supplied as a white product. This product entry covers the primary NDC 23155-850 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
23155-850
Proprietary Name:
Chloroquine Phosphate
Product Type: [3]
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
23155
Product Label ID:
FDA Application Number: [6]
ANDA214756
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
03-20-2023
End Marketing Date: [10]
09-30-2026
Listing Expiration Date: [11]
09-30-2026
Exclude Flag: [12]
D
Product Characteristics
Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
13 MM
Score:
1
Code Structure Chart
Product Details
What is NDC 23155-850?
The NDC code 23155-850 is assigned by the FDA to the product Chloroquine Phosphate. This pharmaceutical product is labeled by Avet Pharmaceuticals Inc. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 23155-850-74. 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?
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.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- CHLOROQUINE PHOSPHATE (UNII: 6E17K3343P)
- CHLOROQUINE (UNII: 886U3H6UFF) (Active Moiety)
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
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 End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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".
