clotrimazole antifungal

Generic: clotrimazole

Labeler: trifecta pharmaceuticals usa, llc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name clotrimazole antifungal
Generic Name clotrimazole
Labeler trifecta pharmaceuticals usa, llc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

clotrimazole 10 g/L

Manufacturer
Trifecta Pharmaceuticals USA, LLC.

Identifiers & Regulatory

Product NDC 69396-143
Product ID 69396-143_11bf503d-be71-0b75-e063-6394a90aa94e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2023-11-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69396143
Hyphenated Format 69396-143

Supplemental Identifiers

RxCUI
309370
UPC
0850058161006
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 antifungal (source: ndc)
Generic Name clotrimazole (source: ndc)
Application Number M005 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 g/L
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (69396-143-33) / .01 L in 1 BOTTLE
source: ndc

Packages (1)

69396-143-33 1 BOTTLE in 1 BOX (69396-143-33) / .01 L in 1 BOTTLE

Ingredients (1)

clotrimazole (10 g/L)

Linked Drug Pages (1)

Clotrimazole Antifungal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "11bf503d-be71-0b75-e063-6394a90aa94e", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0850058161006"], "unii": ["G07GZ97H65"], "rxcui": ["309370"], "spl_set_id": ["11bf50db-552e-0a39-e063-6394a90af60d"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Trifecta Pharmaceuticals USA, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (69396-143-33)  / .01 L in 1 BOTTLE", "package_ndc": "69396-143-33", "marketing_start_date": "20231113"}], "brand_name": "Clotrimazole Antifungal", "product_id": "69396-143_11bf503d-be71-0b75-e063-6394a90aa94e", "dosage_form": "SOLUTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "69396-143", "generic_name": "Clotrimazole", "labeler_name": "Trifecta Pharmaceuticals USA, LLC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Clotrimazole Antifungal", "active_ingredients": [{"name": "CLOTRIMAZOLE", "strength": "10 g/L"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20231113", "listing_expiration_date": "20261231"}