NDC 42385-927 Hydroxychloroquine Sulfate
Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 42385 - Laurus Labs Limited
- 42385-927 - Hydroxychloroquine Sulfate
Product Characteristics
Product Packages
NDC Code 42385-927-01
Package Description: 100 TABLET, FILM COATED in 1 BOTTLE
Price per Unit: $0.21694 per EA
NDC Code 42385-927-05
Package Description: 500 TABLET, FILM COATED in 1 BOTTLE
Price per Unit: $0.21694 per EA
Product Details
What is NDC 42385-927?
What are the uses for Hydroxychloroquine Sulfate?
What are Hydroxychloroquine Sulfate Active Ingredients?
- 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)
Which are Hydroxychloroquine Sulfate UNII Codes?
The UNII codes for the active ingredients in this product are:
- HYDROXYCHLOROQUINE SULFATE (UNII: 8Q2869CNVH)
- HYDROXYCHLOROQUINE (UNII: 4QWG6N8QKH) (Active Moiety)
Which are 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. The UNII codes for the inactive ingredients in this product are:
- CROSPOVIDONE (UNII: 68401960MK)
- LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
- POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
- POLYSORBATE 80 (UNII: 6OZP39ZG8H)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- AMMONIA (UNII: 5138Q19F1X)
- FERROSOFERRIC OXIDE (UNII: XM0M87F357)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- SHELLAC (UNII: MB5IUD6JUA)
What is the NDC to RxNorm Crosswalk for Hydroxychloroquine Sulfate?
- RxCUI: 979092 - hydroxychloroquine sulfate 200 MG Oral Tablet
- RxCUI: 979092 - hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral Tablet
Which are the Pharmacologic Classes for Hydroxychloroquine Sulfate?
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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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[1] 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.
[2] 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.
[3] 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.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] 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.
[8] 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.
[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.
[10] 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.
[12] 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".