antifungal 1% clotrimazole cream

Generic: antifungal 1% clotrimazole cream

Labeler: twincraft inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name antifungal 1% clotrimazole cream
Generic Name antifungal 1% clotrimazole cream
Labeler twincraft inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

clotrimazole 1 g/100mL

Manufacturer
Twincraft Inc.

Identifiers & Regulatory

Product NDC 64412-2010
Product ID 64412-2010_46274158-7d0f-1e12-e063-6294a90a5f4b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2024-10-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 644122010
Hyphenated Format 64412-2010

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 antifungal 1% clotrimazole cream (source: ndc)
Generic Name antifungal 1% clotrimazole cream (source: ndc)
Application Number M005 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100mL
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (64412-2010-1) / 29.5 mL in 1 TUBE
source: ndc

Packages (1)

64412-2010-1 1 TUBE in 1 CARTON (64412-2010-1) / 29.5 mL in 1 TUBE

Ingredients (1)

clotrimazole (1 g/100mL)

Linked Drug Pages (1)

Antifungal 1% Clotrimazole Cream ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "46274158-7d0f-1e12-e063-6294a90a5f4b", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["G07GZ97H65"], "rxcui": ["309367"], "spl_set_id": ["29698d9e-8449-ceee-e063-6394a90a366e"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Twincraft Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (64412-2010-1)  / 29.5 mL in 1 TUBE", "package_ndc": "64412-2010-1", "marketing_start_date": "20241001"}], "brand_name": "Antifungal 1% Clotrimazole Cream", "product_id": "64412-2010_46274158-7d0f-1e12-e063-6294a90a5f4b", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "64412-2010", "generic_name": "Antifungal 1% Clotrimazole Cream", "labeler_name": "Twincraft Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Antifungal 1% Clotrimazole Cream", "active_ingredients": [{"name": "CLOTRIMAZOLE", "strength": "1 g/100mL"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241001", "listing_expiration_date": "20261231"}