clotrimazole

Generic: clotrimazole

Labeler: rugby laboratories, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name clotrimazole
Generic Name clotrimazole
Labeler rugby laboratories, inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

clotrimazole 1 g/100mL

Manufacturer
Rugby Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0536-1443
Product ID 0536-1443_398545dc-cafe-5ab1-e063-6394a90a9d04
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2024-11-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05361443
Hyphenated Format 0536-1443

Supplemental Identifiers

RxCUI
309370
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/100mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0536-1443-70) / 10 mL in 1 BOTTLE
source: ndc

Packages (1)

0536-1443-70 1 BOTTLE in 1 CARTON (0536-1443-70) / 10 mL in 1 BOTTLE

Ingredients (1)

clotrimazole (1 g/100mL)

Linked Drug Pages (1)

CLOTRIMAZOLE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "398545dc-cafe-5ab1-e063-6394a90a9d04", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["G07GZ97H65"], "rxcui": ["309370"], "spl_set_id": ["2c60e631-5930-4420-886d-eb1990c720b6"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Rugby Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0536-1443-70)  / 10 mL in 1 BOTTLE", "package_ndc": "0536-1443-70", "marketing_start_date": "20241121"}], "brand_name": "CLOTRIMAZOLE", "product_id": "0536-1443_398545dc-cafe-5ab1-e063-6394a90a9d04", "dosage_form": "SOLUTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "0536-1443", "generic_name": "CLOTRIMAZOLE", "labeler_name": "Rugby Laboratories, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "CLOTRIMAZOLE", "active_ingredients": [{"name": "CLOTRIMAZOLE", "strength": "1 g/100mL"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241121", "listing_expiration_date": "20261231"}