gembooxt ketoconazole 1% medicated shampoos

Generic: ketoconazole

Labeler: guangdong quadrant ecological technology co., ltd.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name gembooxt ketoconazole 1% medicated shampoos
Generic Name ketoconazole
Labeler guangdong quadrant ecological technology co., ltd.
Dosage Form LIQUID
Routes
TOPICAL
Active Ingredients

ketoconazole .01 g/mL

Manufacturer
Guangdong Quadrant Ecological Technology Co., Ltd.

Identifiers & Regulatory

Product NDC 76986-025
Product ID 76986-025_49965e91-43c4-65d7-e063-6294a90abaec
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2027-12-31
Marketing Start 2026-01-30

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 76986025
Hyphenated Format 76986-025

Supplemental Identifiers

RxCUI
240812
UPC
6977863764681
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 gembooxt ketoconazole 1% medicated shampoos (source: ndc)
Generic Name ketoconazole (source: ndc)
Application Number 505G(a)(3) (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .01 g/mL
source: ndc
Packaging
  • 300 mL in 1 BOTTLE (76986-025-01)
  • 450 mL in 1 BOTTLE (76986-025-02)
  • 750 mL in 1 BOTTLE (76986-025-03)
source: ndc

Packages (3)

76986-025-01 300 mL in 1 BOTTLE (76986-025-01) 76986-025-02 450 mL in 1 BOTTLE (76986-025-02) 76986-025-03 750 mL in 1 BOTTLE (76986-025-03)

Ingredients (1)

ketoconazole (.01 g/mL)

Linked Drug Pages (1)

Gembooxt Ketoconazole 1% Medicated Shampoos ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "49965e91-43c4-65d7-e063-6294a90abaec", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000190115", "N0000185503"], "upc": ["6977863764681"], "unii": ["R9400W927I"], "rxcui": ["240812"], "spl_set_id": ["49965e91-43c3-65d7-e063-6294a90abaec"], "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": ["Guangdong Quadrant Ecological Technology Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "300 mL in 1 BOTTLE (76986-025-01)", "package_ndc": "76986-025-01", "marketing_start_date": "20260130"}, {"sample": false, "description": "450 mL in 1 BOTTLE (76986-025-02)", "package_ndc": "76986-025-02", "marketing_start_date": "20260130"}, {"sample": false, "description": "750 mL in 1 BOTTLE (76986-025-03)", "package_ndc": "76986-025-03", "marketing_start_date": "20260130"}], "brand_name": "Gembooxt Ketoconazole 1% Medicated Shampoos", "product_id": "76986-025_49965e91-43c4-65d7-e063-6294a90abaec", "dosage_form": "LIQUID", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 3A5 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "76986-025", "generic_name": "KETOCONAZOLE", "labeler_name": "Guangdong Quadrant Ecological Technology Co., Ltd.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Gembooxt Ketoconazole 1% Medicated Shampoos", "active_ingredients": [{"name": "KETOCONAZOLE", "strength": ".01 g/mL"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20260130", "listing_expiration_date": "20271231"}