nizoral

Generic: ketoconazole

Labeler: kramer laboratories
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nizoral
Generic Name ketoconazole
Labeler kramer laboratories
Dosage Form SHAMPOO
Routes
TOPICAL
Active Ingredients

ketoconazole 10 mg/mL

Manufacturer
Kramer Laboratories

Identifiers & Regulatory

Product NDC 55505-196
Product ID 55505-196_038d4560-e41d-430e-a2ad-08ade2335281
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA020310
Listing Expiration 2026-12-31
Marketing Start 2022-06-16

Pharmacologic Class

Established (EPC)
azole antifungal [epc]
Mechanism of Action
cytochrome p450 3a4 inhibitors [moa] cytochrome p450 3a5 inhibitors [moa] p-glycoprotein inhibitors [moa]
Chemical Structure
azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55505196
Hyphenated Format 55505-196

Supplemental Identifiers

RxCUI
240812 608844
UNII
R9400W927I
NUI
N0000175487 M0002083 N0000182141 N0000190115 N0000185503

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nizoral (source: ndc)
Generic Name ketoconazole (source: ndc)
Application Number NDA020310 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (55505-196-33) / 125 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (55505-196-40) / 200 mL in 1 BOTTLE
  • 4 mL in 1 PACKET (55505-196-47)
  • 2 BOTTLE in 1 CARTON (55505-196-57) / 200 mL in 1 BOTTLE
  • 1 CARTON in 1 CARTON (55505-196-65) / 400 mL in 1 CARTON
  • 3 BOTTLE in 1 CARTON (55505-196-68) / 200 mL in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (55505-196-72) / 325 mL in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (55505-196-84) / 400 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (55505-196-85) / 562 mL in 1 BOTTLE
source: ndc

Packages (9)

55505-196-33 1 BOTTLE in 1 CARTON (55505-196-33) / 125 mL in 1 BOTTLE 55505-196-40 1 BOTTLE in 1 CARTON (55505-196-40) / 200 mL in 1 BOTTLE 55505-196-47 4 mL in 1 PACKET (55505-196-47) 55505-196-57 2 BOTTLE in 1 CARTON (55505-196-57) / 200 mL in 1 BOTTLE 55505-196-65 1 CARTON in 1 CARTON (55505-196-65) / 400 mL in 1 CARTON 55505-196-68 3 BOTTLE in 1 CARTON (55505-196-68) / 200 mL in 1 BOTTLE 55505-196-72 2 BOTTLE in 1 CARTON (55505-196-72) / 325 mL in 1 BOTTLE 55505-196-84 2 BOTTLE in 1 CARTON (55505-196-84) / 400 mL in 1 BOTTLE 55505-196-85 1 BOTTLE in 1 CARTON (55505-196-85) / 562 mL in 1 BOTTLE

Ingredients (1)

ketoconazole (10 mg/mL)

Linked Drug Pages (1)

Nizoral ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "038d4560-e41d-430e-a2ad-08ade2335281", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000190115", "N0000185503"], "unii": ["R9400W927I"], "rxcui": ["240812", "608844"], "spl_set_id": ["a17b7424-ee7e-4fcc-b6b3-0904932ae319"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "pharm_class_moa": ["Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 3A5 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Kramer Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (55505-196-33)  / 125 mL in 1 BOTTLE", "package_ndc": "55505-196-33", "marketing_start_date": "20220616"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (55505-196-40)  / 200 mL in 1 BOTTLE", "package_ndc": "55505-196-40", "marketing_start_date": "20220616"}, {"sample": false, "description": "4 mL in 1 PACKET (55505-196-47)", "package_ndc": "55505-196-47", "marketing_start_date": "20240301"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (55505-196-57)  / 200 mL in 1 BOTTLE", "package_ndc": "55505-196-57", "marketing_start_date": "20230429"}, {"sample": false, "description": "1 CARTON in 1 CARTON (55505-196-65)  / 400 mL in 1 CARTON", "package_ndc": "55505-196-65", "marketing_start_date": "20220616"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (55505-196-68)  / 200 mL in 1 BOTTLE", "package_ndc": "55505-196-68", "marketing_start_date": "20221015"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (55505-196-72)  / 325 mL in 1 BOTTLE", "package_ndc": "55505-196-72", "marketing_start_date": "20231201"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (55505-196-84)  / 400 mL in 1 BOTTLE", "package_ndc": "55505-196-84", "marketing_start_date": "20250601"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (55505-196-85)  / 562 mL in 1 BOTTLE", "package_ndc": "55505-196-85", "marketing_start_date": "20260112"}], "brand_name": "Nizoral", "product_id": "55505-196_038d4560-e41d-430e-a2ad-08ade2335281", "dosage_form": "SHAMPOO", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 3A5 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "55505-196", "generic_name": "Ketoconazole", "labeler_name": "Kramer Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nizoral", "active_ingredients": [{"name": "KETOCONAZOLE", "strength": "10 mg/mL"}], "application_number": "NDA020310", "marketing_category": "NDA", "marketing_start_date": "20220616", "listing_expiration_date": "20261231"}