NDC 43353-051 Hydroxychloroquine Sulfate
Tablet Oral

Product Information

Hydroxychloroquine Sulfate is a human prescription drug product labeled by Aphena Pharma Solutions - Tennessee, Llc. The product's dosage form is tablet and is administered via oral form.

Product Code43353-051
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Hydroxychloroquine Sulfate
Non-Proprietary Name 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.
Hydroxychloroquine Sulfate
Product Type 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.
Human Prescription Drug
Dosage FormTablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Aphena Pharma Solutions - Tennessee, Llc
Labeler Code43353
FDA Application Number 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.
NDA009768
Marketing Category 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.
NDA AUTHORIZED GENERIC - A product marketed as a “generic” drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
12-12-2014
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Hydroxychloroquine Sulfate?


Product Characteristics

Color(s)WHITE (C48325)
ShapeDOUBLE CIRCLE (C48339)
Size(s)12 MM
Imprint(s)PLAQUENIL
Score1

Product Packages

NDC 43353-051-09

Package Description: 9000 TABLET in 1 BOTTLE

NDC 43353-051-53

Package Description: 60 TABLET in 1 BOTTLE

NDC 43353-051-60

Package Description: 90 TABLET in 1 BOTTLE

NDC 43353-051-80

Package Description: 180 TABLET in 1 BOTTLE

Product Details

What are Hydroxychloroquine Sulfate 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.
  • HYDROXYCHLOROQUINE SULFATE 200 mg/1 - A chemotherapeutic agent that acts against erythrocytic forms of malarial parasites. Hydroxychloroquine appears to concentrate in food vacuoles of affected protozoa. It inhibits plasmodial heme polymerase. (From Gilman et al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9th ed, p970)

Hydroxychloroquine Sulfate Active Ingredients UNII Codes

  • HYDROXYCHLOROQUINE SULFATE (UNII: 8Q2869CNVH)
  • HYDROXYCHLOROQUINE (UNII: 4QWG6N8QKH) (Active Moiety)

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 979092 - hydroxychloroquine sulfate 200 MG Oral Tablet
  • RxCUI: 979092 - hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral Tablet

Hydroxychloroquine Sulfate Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Hydroxychloroquine

Hydroxychloroquine is pronounced as (hye drox ee klor' oh kwin)

Why is hydroxychloroquine medication prescribed?
Hydroxychloroquine is in a class of drugs called antimalarials. It is used to prevent and treat acute attacks of malaria. It is also used to treat discoid or systemic lup...
[Read More]

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Hydroxychloroquine Sulfate Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Repackaging Information



Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count200mg
6043353-051-53
9043353-051-60
18043353-051-80
900043353-051-09

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:


Cookeville, TN 38506

20170821JH


Principal Display Panel



NDC 43353-051 - Hydroxychloroquine Sulfate 200mg - Rx Only


* Please review the disclaimer below.