Hydroxychloroquine Sulfate
NDC 68071-2912

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 68071-2912?
  5. Hydroxychloroquine Sulfate Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Hydroxychloroquine Sulfate is a ANDA-approved product labeled by Nucare Pharmaceuticals,inc.. Hydroxychloroquine 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 68071-2912 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
68071-2912
Proprietary Name:
Hydroxychloroquine Sulfate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Nucare Pharmaceuticals,inc.
Labeler Code:
68071
Product Label ID:
f2002851-852f-4ee8-e053-2a95a90a242d
FDA Application Number: [6]
ANDA040657
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
01-03-2008
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
I

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)
Shape:
OVAL (C48345)
Size(s):
13 MM
Imprint(s):
ZC38
Score:
1

Code Structure Chart

Product Details

What is NDC 68071-2912?

The NDC code 68071-2912 is assigned by the FDA to the product Hydroxychloroquine Sulfate. This pharmaceutical product is labeled by Nucare Pharmaceuticals,inc. and is currently categorized as listed product. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 68071-2912-2, 68071-2912-3, 68071-2912-9. 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?

Hydroxychloroquine is used to prevent or treat malaria caused by mosquito bites. The United States Center for Disease Control provides 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. This medication is also used to treat certain auto-immune diseases (lupus, rheumatoid arthritis). It belongs to a class of medications known as disease-modifying antirheumatic drugs (DMARDs). It can reduce skin problems in lupus and prevent swelling/pain in arthritis. Hydroxychloroquine 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:

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

Which are the Inactive Ingredients associated 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. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

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

* Please review the full disclaimer at the bottom of this page.

Patient Education

Hydroxychloroquine


Hydroxychloroquine is used to prevent and treat acute attacks of malaria in adults and children weighing more than 31 kg (68 lbs). It is also used to treat discoid lupus erythematosus (DLE; a chronic inflammatory condition of the skin) or systemic lupus erythematosus (SLE or lupus; an autoimmune disease in which the immune system attacks healthy parts of the body such as joints, skin, blood vessels, and organs) and rheumatoid arthritis. Hydroxychloroquine is in a class of drugs called antimalarials and is also an antirheumatic drug. It works by killing the organisms that cause malaria. Hydroxychloroquine may work to treat rheumatoid arthritis and systemic lupus erythematosus by decreasing the activity of the immune system.
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* 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 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".