NDC 63629-8675 Ketoconazole
Shampoo, Suspension Topical - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Code Structure Chart
Product Details
What is NDC 63629-8675?
What are the uses for Ketoconazole?
What are Ketoconazole Active Ingredients?
- KETOCONAZOLE 20 mg/mL - Broad spectrum antifungal agent used for long periods at high doses, especially in immunosuppressed patients.
Which are Ketoconazole UNII Codes?
The UNII codes for the active ingredients in this product are:
- KETOCONAZOLE (UNII: R9400W927I)
- KETOCONAZOLE (UNII: R9400W927I) (Active Moiety)
Which are Ketoconazole 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:
- COCO DIETHANOLAMIDE (UNII: 92005F972D)
- DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
- FD&C RED NO. 40 (UNII: WZB9127XOA)
- HYDROCHLORIC ACID (UNII: QTT17582CB)
- IMIDUREA (UNII: M629807ATL)
- PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
- SODIUM CHLORIDE (UNII: 451W47IQ8X)
- SODIUM HYDROXIDE (UNII: 55X04QC32I)
- WATER (UNII: 059QF0KO0R)
- SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
What is the NDC to RxNorm Crosswalk for Ketoconazole?
- RxCUI: 106336 - ketoconazole 2 % Medicated Shampoo
- RxCUI: 106336 - ketoconazole 20 MG/ML Medicated Shampoo
Which are the Pharmacologic Classes for Ketoconazole?
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Patient Education
Ketoconazole Topical
Ketoconazole cream is used to treat tinea corporis (ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes), tinea versicolor (fungal infection of the skin that causes brown or light colored spots on the chest, back, arms, legs, or neck), and yeast infections of the skin. Prescription ketoconazole shampoo is used to treat tinea versicolor. Over-the-counter ketoconazole shampoo is used to control flaking, scaling, and itching of the scalp caused by dandruff. Ketoconazole is in a class of antifungal medications called imidazoles. It works by slowing the growth of fungi that cause infection.
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* Please review the disclaimer below.
[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.
[11] 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] 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".