ketoconazole

Generic: ketoconazole

Labeler: e. fougera & co. a division of fougera pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketoconazole
Generic Name ketoconazole
Labeler e. fougera & co. a division of fougera pharmaceuticals, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

ketoconazole 20 mg/g

Manufacturer
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 0168-0099
Product ID 0168-0099_6eaf555f-3e9c-4811-ae1f-66afda8b2b11
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076294
Listing Expiration 2027-12-31
Marketing Start 2004-04-28

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 01680099
Hyphenated Format 0168-0099

Supplemental Identifiers

RxCUI
203088
UPC
0301680099156
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 ketoconazole (source: ndc)
Generic Name ketoconazole (source: ndc)
Application Number ANDA076294 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0168-0099-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0168-0099-30) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0168-0099-60) / 60 g in 1 TUBE
source: ndc

Packages (3)

0168-0099-15 1 TUBE in 1 CARTON (0168-0099-15) / 15 g in 1 TUBE 0168-0099-30 1 TUBE in 1 CARTON (0168-0099-30) / 30 g in 1 TUBE 0168-0099-60 1 TUBE in 1 CARTON (0168-0099-60) / 60 g in 1 TUBE

Ingredients (1)

ketoconazole (20 mg/g)

Linked Drug Pages (1)

ketoconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "6eaf555f-3e9c-4811-ae1f-66afda8b2b11", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000190115", "N0000185503"], "upc": ["0301680099156"], "unii": ["R9400W927I"], "rxcui": ["203088"], "spl_set_id": ["cad7c647-34a9-4e4e-83b3-8d78e58f588f"], "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": ["E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0168-0099-15)  / 15 g in 1 TUBE", "package_ndc": "0168-0099-15", "marketing_start_date": "20040428"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0168-0099-30)  / 30 g in 1 TUBE", "package_ndc": "0168-0099-30", "marketing_start_date": "20040428"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0168-0099-60)  / 60 g in 1 TUBE", "package_ndc": "0168-0099-60", "marketing_start_date": "20040428"}], "brand_name": "ketoconazole", "product_id": "0168-0099_6eaf555f-3e9c-4811-ae1f-66afda8b2b11", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 3A5 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "0168-0099", "generic_name": "ketoconazole", "labeler_name": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ketoconazole", "active_ingredients": [{"name": "KETOCONAZOLE", "strength": "20 mg/g"}], "application_number": "ANDA076294", "marketing_category": "ANDA", "marketing_start_date": "20040428", "listing_expiration_date": "20271231"}