ketoconazole

Generic: ketoconazole foam

Labeler: xiromed, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketoconazole
Generic Name ketoconazole foam
Labeler xiromed, llc
Dosage Form AEROSOL, FOAM
Routes
TOPICAL
Active Ingredients

ketoconazole 20 mg/g

Manufacturer
Xiromed, LLC

Identifiers & Regulatory

Product NDC 70700-160
Product ID 70700-160_1d2842b4-06d6-8054-d485-cb30f0ed4f69
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213601
Listing Expiration 2026-12-31
Marketing Start 2021-05-21

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 70700160
Hyphenated Format 70700-160

Supplemental Identifiers

RxCUI
728550
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 foam (source: ndc)
Application Number ANDA213601 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/g
source: ndc
Packaging
  • 50 g in 1 CAN (70700-160-19)
  • 100 g in 1 CAN (70700-160-20)
source: ndc

Packages (2)

70700-160-19 50 g in 1 CAN (70700-160-19) 70700-160-20 100 g in 1 CAN (70700-160-20)

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": "1d2842b4-06d6-8054-d485-cb30f0ed4f69", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000190115", "N0000185503"], "unii": ["R9400W927I"], "rxcui": ["728550"], "spl_set_id": ["ea319889-5e58-f778-3009-5ba6a5f2690a"], "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": ["Xiromed, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 g in 1 CAN (70700-160-19)", "package_ndc": "70700-160-19", "marketing_start_date": "20210521"}, {"sample": false, "description": "100 g in 1 CAN (70700-160-20)", "package_ndc": "70700-160-20", "marketing_start_date": "20210521"}], "brand_name": "Ketoconazole", "product_id": "70700-160_1d2842b4-06d6-8054-d485-cb30f0ed4f69", "dosage_form": "AEROSOL, FOAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 3A5 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "70700-160", "generic_name": "Ketoconazole Foam", "labeler_name": "Xiromed, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketoconazole", "active_ingredients": [{"name": "KETOCONAZOLE", "strength": "20 mg/g"}], "application_number": "ANDA213601", "marketing_category": "ANDA", "marketing_start_date": "20210521", "listing_expiration_date": "20261231"}