Nizoral

Ketoconazole

Kramer Laboratories
Human Otc Drug
NDC 55505-196

Nizoral also known as Ketoconazole is a human otc drug labeled by 'Kramer Laboratories'. National Drug Code (NDC) number for Nizoral is 55505-196. This drug is available in dosage form of Shampoo. The names of the active, medicinal ingredients in Nizoral drug includes Ketoconazole - 10 mg/mL . The currest status of Nizoral drug is Active.

Drug Information:

Drug NDC:	55505-196
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.
Proprietary Name:	Nizoral
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Ketoconazole
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Kramer Laboratories
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Shampoo
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	KETOCONAZOLE - 10 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	NDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	16 Jun, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	05 May, 2026
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.
Application Number:	NDA020310
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.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Kramer Laboratories
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	240812 608844
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000175487 M0002083 N0000182141 N0000190115 N0000185503
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	R9400W927I
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class MOA:	Cytochrome P450 3A4 Inhibitors [MoA] Cytochrome P450 3A5 Inhibitors [MoA] P-Glycoprotein Inhibitors [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:	Azole Antifungal [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class CS:	Azoles [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Azole Antifungal [EPC] Azoles [CS] Cytochrome P450 3A4 Inhibitors [MoA] Cytochrome P450 3A5 Inhibitors [MoA] P-Glycoprotein Inhibitors [MoA]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
55505-196-33	1 BOTTLE in 1 CARTON (55505-196-33) / 125 mL in 1 BOTTLE	16 Jun, 2022	N/A	No
55505-196-40	1 BOTTLE in 1 CARTON (55505-196-40) / 200 mL in 1 BOTTLE	16 Jun, 2022	N/A	No
55505-196-64	1 BOTTLE in 1 CARTON (55505-196-64) / 325 mL in 1 BOTTLE	16 Jun, 2022	N/A	No
55505-196-65	1 CARTON in 1 CARTON (55505-196-65) / 400 mL in 1 CARTON	16 Jun, 2022	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Nizoral

Ketoconazole

Shampoo
Kramer Laboratories
NDC: 55505-196

Nizoral

Ketoconazole

Shampoo
Kramer Laboratories
NDC: 55505-192

Purpose:

Active ingredient purpose ketoconazole 1% w/w anti-dandruff shampoo

Product Elements:

Nizoral ketoconazole ketoconazole ketoconazole benzyl alcohol butylated hydroxytoluene fd&c blue no. 1 citric acid monohydrate coco monoethanolamide glycol distearate hydrochloric acid hypromellose, unspecified polyquaternium-7 (70/30 acrylamide/dadmac; 1600000 mw) sodium chloride sodium cocoyl sarcosinate sodium hydroxide sodium laureth-3 sulfate edetate sodium water 200 ml front 125 ml front 325ml front 400 ml front carton label

Indications and Usage:

Uses controls flaking, scaling and itching associated with dandruff

Warnings:

Warnings for external use only

Do Not Use:

Warnings for external use only

When Using:

When using this product avoid contact with eyes if product gets into eyes, rinse thoroughly with water

Dosage and Administration:

Directions adults and children 12 years and over wet hair thoroughly apply shampoo, generously lather, rinse thoroughly. repeat use every 3-4 days for up to 8 weeks or as directed by a doctor. then use only as needed to control dandruff children under 12 years ask a doctor

Package Label Principal Display Panel:

Principal display panel nizoral Â® anti-dandruff ketoconazole 1% anti-dandruff shampoo anti-dandruff shampoo clinically proven to control flaking, scaling and itching from dandruff controls fungus that can cause dandruff clean fresh scent 7 fl oz (200ml) what causes dandruff? dandruff can have many causes. a fungus found on every human head is often associated with dandruff. how does nizoral Â® anti-dandruff work? nizoral Â® anti-dandruff is the only over-the-counter anti-dandruff shampoo that has ketoconazole, an effective antifungal. ketoconazole works by controlling fungus often associated with dandruff, and once the fungus is controlled, so are your dandruff symptoms. use nizoral Â® anti-dandruff just twice a week to control your dandruff symptoms. before use, read all label information. if you have a drug reaction, contact a doctor and report it by calling: 1.800.824.4894 kramer laboratories made in canada distributed by: kramer laboratories, inc. bridgewater, nj 08807 usa Â© 2022 kramer laboratories, inc. lot: exp: p819b46100 nizoral Â® anti-dandruff ketoconazole 1% anti-dandruff shampoo controls fungus that can cause dandruff nizoral Â® anti-dandruff ketoconazole 1% anti-dandruff shampoo anti-dandruff shampoo clinically proven to control flaking, scaling and itching from dandruff controls fungus that can cause dandruff clean fresh scent 7 fl oz (200ml) p819h46000 nizoral Â® anti-dandruff ketoconazole 1% anti-dandruff shampoo anti-dandruff shampoo clinically proven to control flaking, scaling and itching from dandruff controls fungus that can cause dandruff clean fresh scent 4 fl oz (125ml) p809h45000 nizoral Â® anti-dandruff ketoconazole 1% anti-dandruff shampoo anti-dandruff shampoo clinically proven to control flaking, scaling and itching from dandruff controls fungus that can cause dandruff clean fresh scent 11 fl oz (325ml) p829h47000 nizoral Â® anti-dandruff ketoconazole 1% anti-dandruff shampoo anti-dandruff shampoo clinically proven to control flaking, scaling and itching from dandruff controls fungus that can cause dandruff clean fresh scent 14 fl oz (400 ml) p839h48000

Further Questions:

Questions or comments? call 1-800-824-4894

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.