ketoconazole

Generic: ketoconazole cream, 2%

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketoconazole
Generic Name ketoconazole cream, 2%
Labeler proficient rx lp
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

ketoconazole 20 mg/g

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-091
Product ID 82804-091_36e0bdcb-845c-452f-ad5a-a116ad657a3a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212443
Listing Expiration 2026-12-31
Marketing Start 2021-05-27

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 82804091
Hyphenated Format 82804-091

Supplemental Identifiers

RxCUI
203088
UPC
0382804091157
UNII
R9400W927I
NUI
N0000175487 M0002083 N0000182141 N0000190115 N0000185503

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 cream, 2% (source: ndc)
Application Number ANDA212443 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (82804-091-15) / 15 g in 1 TUBE
source: ndc

Packages (1)

82804-091-15 1 TUBE in 1 CARTON (82804-091-15) / 15 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": "36e0bdcb-845c-452f-ad5a-a116ad657a3a", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000190115", "N0000185503"], "upc": ["0382804091157"], "unii": ["R9400W927I"], "rxcui": ["203088"], "spl_set_id": ["36e0bdcb-845c-452f-ad5a-a116ad657a3a"], "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": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (82804-091-15)  / 15 g in 1 TUBE", "package_ndc": "82804-091-15", "marketing_start_date": "20240328"}], "brand_name": "Ketoconazole", "product_id": "82804-091_36e0bdcb-845c-452f-ad5a-a116ad657a3a", "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": "82804-091", "generic_name": "Ketoconazole Cream, 2%", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketoconazole", "active_ingredients": [{"name": "KETOCONAZOLE", "strength": "20 mg/g"}], "application_number": "ANDA212443", "marketing_category": "ANDA", "marketing_start_date": "20210527", "listing_expiration_date": "20261231"}