62135-717 NDC - CHLOROQUINE PHOSPHATE (CHLOROQUINE PHOSPHATE)

Drug Information

Product NDC: 62135-717
Proprietary Name: CHLOROQUINE PHOSPHATE
Non Proprietary Name: chloroquine phosphate
Active Ingredient(s): 500 mg/1 CHLOROQUINE PHOSPHATE
Administration Route(s): ORAL
Dosage Form(s): TABLET, COATED
Pharmacy Class(es): Antimalarial [EPC]

Labeler Information

Field Name	Field Value
Labeler Name:	Chartwell RX, LLC
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:	ANDA214756
Marketing Category:	ANDA
Start Marketing Date:	3/20/2023

Package Information

No.	Package Code	Package Description	Billing Unit
1	62135-717-26	25 TABLET, COATED in 1 BOTTLE (62135-717-26)	EA

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	62135-717	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAME	HUMAN PRESCRIPTION DRUG	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME	CHLOROQUINE PHOSPHATE	This is the date that the labeler indicates was the start of its marketing of the drug product.
NON PROPRIETARY NAME	chloroquine phosphate	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.
DOSAGE FORM NAME	TABLET, COATED	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.
ROUTE NAME	ORAL	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.
START MARKETING DATE	3/20/2023	Name of Company corresponding to the labeler code segment of the Product NDC.
MARKETING CATEGORY NAME	ANDA	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.
APPLICATION NUMBER	ANDA214756	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.
LABELER NAME	Chartwell RX, LLC	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	CHLOROQUINE PHOSPHATE	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.
ACTIVE NUMERATOR STRENGTH	500
ACTIVE INGRED UNIT	mg/1
PHARM CLASSES	Antimalarial [EPC]

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This page was last updated on: 12/6/2025

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