ketoconazole

Generic: ketoconazole

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketoconazole
Generic Name ketoconazole
Labeler ani pharmaceuticals, inc.
Dosage Form SHAMPOO
Routes
TOPICAL
Active Ingredients

ketoconazole 20 mg/mL

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-662
Product ID 70954-662_8aec6ed1-af2d-415f-bb5f-e56da3045deb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218498
Listing Expiration 2027-12-31
Marketing Start 2024-09-16

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 70954662
Hyphenated Format 70954-662

Supplemental Identifiers

RxCUI
106336
UPC
0370954662105
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 ANDA218498 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE, PLASTIC (70954-662-10)
source: ndc

Packages (1)

70954-662-10 120 mL in 1 BOTTLE, PLASTIC (70954-662-10)

Ingredients (1)

ketoconazole (20 mg/mL)

Linked Drug Pages (1)

Ketoconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "8aec6ed1-af2d-415f-bb5f-e56da3045deb", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000190115", "N0000185503"], "upc": ["0370954662105"], "unii": ["R9400W927I"], "rxcui": ["106336"], "spl_set_id": ["00c1cac8-a865-4583-aaba-3a0f21fb31e6"], "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": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE, PLASTIC (70954-662-10)", "package_ndc": "70954-662-10", "marketing_start_date": "20240916"}], "brand_name": "Ketoconazole", "product_id": "70954-662_8aec6ed1-af2d-415f-bb5f-e56da3045deb", "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": "70954-662", "generic_name": "Ketoconazole", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketoconazole", "active_ingredients": [{"name": "KETOCONAZOLE", "strength": "20 mg/mL"}], "application_number": "ANDA218498", "marketing_category": "ANDA", "marketing_start_date": "20240916", "listing_expiration_date": "20271231"}