clotrimazole

Generic: drs. clotrimazole

Labeler: ol pharma tech,llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name clotrimazole
Generic Name drs. clotrimazole
Labeler ol pharma tech,llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

clotrimazole 10 mg/g

Manufacturer
OL PHARMA TECH,LLC

Identifiers & Regulatory

Product NDC 80489-002
Product ID 80489-002_2b522583-1d23-f3bb-e063-6394a90a76a7
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2021-01-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80489002
Hyphenated Format 80489-002

Supplemental Identifiers

RxCUI
309367
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 drs. clotrimazole (source: ndc)
Application Number M005 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (80489-002-01) / 28.3 g in 1 TUBE
source: ndc

Packages (1)

80489-002-01 1 TUBE in 1 CARTON (80489-002-01) / 28.3 g in 1 TUBE

Ingredients (1)

clotrimazole (10 mg/g)

Linked Drug Pages (1)

Clotrimazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "2b522583-1d23-f3bb-e063-6394a90a76a7", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["G07GZ97H65"], "rxcui": ["309367"], "spl_set_id": ["b0e9fc77-6d5c-2472-e053-2995a90a3de4"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["OL PHARMA TECH,LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (80489-002-01)  / 28.3 g in 1 TUBE", "package_ndc": "80489-002-01", "marketing_start_date": "20210101"}], "brand_name": "Clotrimazole", "product_id": "80489-002_2b522583-1d23-f3bb-e063-6394a90a76a7", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "80489-002", "generic_name": "Drs. Clotrimazole", "labeler_name": "OL PHARMA TECH,LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Clotrimazole", "active_ingredients": [{"name": "CLOTRIMAZOLE", "strength": "10 mg/g"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210101", "listing_expiration_date": "20261231"}