clotrimazole

Generic: clotrimazole

Labeler: granules usa, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name clotrimazole
Generic Name clotrimazole
Labeler granules usa, inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

clotrimazole 1 g/mL

Manufacturer
Granules USA, Inc.

Identifiers & Regulatory

Product NDC 69848-001
Product ID 69848-001_4690b8d8-7cc2-ebf2-e063-6294a90af113
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2018-07-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69848001
Hyphenated Format 69848-001

Supplemental Identifiers

UPC
0813874020513
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
  • 10 mL in 1 BOTTLE (69848-001-01)
source: ndc

Packages (1)

69848-001-01 10 mL in 1 BOTTLE (69848-001-01)

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": "4690b8d8-7cc2-ebf2-e063-6294a90af113", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0813874020513"], "unii": ["G07GZ97H65"], "spl_set_id": ["6e63e29a-eb50-1790-e053-2a91aa0a3616"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Granules USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 BOTTLE (69848-001-01)", "package_ndc": "69848-001-01", "marketing_start_date": "20180701"}], "brand_name": "Clotrimazole", "product_id": "69848-001_4690b8d8-7cc2-ebf2-e063-6294a90af113", "dosage_form": "SOLUTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "69848-001", "generic_name": "Clotrimazole", "labeler_name": "Granules USA, Inc.", "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": "20180701", "listing_expiration_date": "20261231"}