ketoconazole

Generic: ketoconazole

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketoconazole
Generic Name ketoconazole
Labeler northstar rx llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

ketoconazole 20 mg/g

Manufacturer
NORTHSTAR RX LLC

Identifiers & Regulatory

Product NDC 16714-955
Product ID 16714-955_494f72d9-37d0-5066-e063-6394a90a95bc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075638
Listing Expiration 2027-12-31
Marketing Start 2002-12-18

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 16714955
Hyphenated Format 16714-955

Supplemental Identifiers

RxCUI
203088
UPC
0316714955025
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 ANDA075638 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (16714-955-01) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (16714-955-02) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (16714-955-03) / 60 g in 1 TUBE
source: ndc

Packages (3)

16714-955-01 1 TUBE in 1 CARTON (16714-955-01) / 15 g in 1 TUBE 16714-955-02 1 TUBE in 1 CARTON (16714-955-02) / 30 g in 1 TUBE 16714-955-03 1 TUBE in 1 CARTON (16714-955-03) / 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": "494f72d9-37d0-5066-e063-6394a90a95bc", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000190115", "N0000185503"], "upc": ["0316714955025"], "unii": ["R9400W927I"], "rxcui": ["203088"], "spl_set_id": ["bf3e48fd-e063-42e6-acd1-580ddc6e93be"], "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": ["NORTHSTAR RX LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (16714-955-01)  / 15 g in 1 TUBE", "package_ndc": "16714-955-01", "marketing_start_date": "20190425"}, {"sample": false, "description": "1 TUBE in 1 CARTON (16714-955-02)  / 30 g in 1 TUBE", "package_ndc": "16714-955-02", "marketing_start_date": "20190425"}, {"sample": false, "description": "1 TUBE in 1 CARTON (16714-955-03)  / 60 g in 1 TUBE", "package_ndc": "16714-955-03", "marketing_start_date": "20190425"}], "brand_name": "Ketoconazole", "product_id": "16714-955_494f72d9-37d0-5066-e063-6394a90a95bc", "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": "16714-955", "generic_name": "Ketoconazole", "labeler_name": "NORTHSTAR RX LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketoconazole", "active_ingredients": [{"name": "KETOCONAZOLE", "strength": "20 mg/g"}], "application_number": "ANDA075638", "marketing_category": "ANDA", "marketing_start_date": "20021218", "listing_expiration_date": "20271231"}