clotrimazole

Generic: clotrimazole

Labeler: avpak
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name clotrimazole
Generic Name clotrimazole
Labeler avpak
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

clotrimazole 1 g/mL

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-044
Product ID 50268-044_3ca3b5b8-e45f-0bff-e063-6394a90acf23
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2025-08-18

Pharmacologic Class

Established (EPC)
azole antifungal [epc]
Chemical Structure
azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268044
Hyphenated Format 50268-044

Supplemental Identifiers

UPC
0350268044309
UNII
G07GZ97H65
NUI
N0000175487 M0002083

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 clotrimazole (source: ndc)
Generic Name clotrimazole (source: ndc)
Application Number M005 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (50268-044-30) / 30 mL in 1 BOTTLE
source: ndc

Packages (1)

50268-044-30 1 BOTTLE in 1 CARTON (50268-044-30) / 30 mL in 1 BOTTLE

Ingredients (1)

clotrimazole (1 g/mL)

Linked Drug Pages (1)

Clotrimazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3ca3b5b8-e45f-0bff-e063-6394a90acf23", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0350268044309"], "unii": ["G07GZ97H65"], "spl_set_id": ["3ca3b475-7b69-442a-e063-6294a90a7b3f"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["AvPAK"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50268-044-30)  / 30 mL in 1 BOTTLE", "package_ndc": "50268-044-30", "marketing_start_date": "20250818"}], "brand_name": "Clotrimazole", "product_id": "50268-044_3ca3b5b8-e45f-0bff-e063-6394a90acf23", "dosage_form": "SOLUTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "50268-044", "generic_name": "Clotrimazole", "labeler_name": "AvPAK", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Clotrimazole", "active_ingredients": [{"name": "CLOTRIMAZOLE", "strength": "1 g/mL"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250818", "listing_expiration_date": "20261231"}