clotrimazole topical solution usp, 1%

Generic: clotrimazole topical solution usp, 1%

Labeler: akron pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clotrimazole topical solution usp, 1%
Generic Name clotrimazole topical solution usp, 1%
Labeler akron pharma inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

clotrimazole 10 mg/mL

Manufacturer
Akron Pharma Inc.

Identifiers & Regulatory

Product NDC 71399-0666
Product ID 71399-0666_5fbee99b-e93b-4682-9629-98f4f65587fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216569
Listing Expiration 2026-12-31
Marketing Start 2023-10-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713990666
Hyphenated Format 71399-0666

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 topical solution usp, 1% (source: ndc)
Generic Name clotrimazole topical solution usp, 1% (source: ndc)
Application Number ANDA216569 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (71399-0666-3) / 30 mL in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (71399-0666-6) / 30 mL in 1 BOTTLE
source: ndc

Packages (2)

71399-0666-3 1 BOTTLE in 1 CARTON (71399-0666-3) / 30 mL in 1 BOTTLE 71399-0666-6 2 BOTTLE in 1 CARTON (71399-0666-6) / 30 mL in 1 BOTTLE

Ingredients (1)

clotrimazole (10 mg/mL)

Linked Drug Pages (1)

Clotrimazole Topical Solution USP, 1% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "5fbee99b-e93b-4682-9629-98f4f65587fa", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["G07GZ97H65"], "rxcui": ["309370"], "spl_set_id": ["32b968ce-e112-441c-a91f-c62f2f67b57c"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Akron Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (71399-0666-3)  / 30 mL in 1 BOTTLE", "package_ndc": "71399-0666-3", "marketing_start_date": "20240504"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (71399-0666-6)  / 30 mL in 1 BOTTLE", "package_ndc": "71399-0666-6", "marketing_start_date": "20240325"}], "brand_name": "Clotrimazole Topical Solution USP, 1%", "product_id": "71399-0666_5fbee99b-e93b-4682-9629-98f4f65587fa", "dosage_form": "SOLUTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "71399-0666", "generic_name": "Clotrimazole Topical Solution USP, 1%", "labeler_name": "Akron Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clotrimazole Topical Solution USP, 1%", "active_ingredients": [{"name": "CLOTRIMAZOLE", "strength": "10 mg/mL"}], "application_number": "ANDA216569", "marketing_category": "ANDA", "marketing_start_date": "20231016", "listing_expiration_date": "20261231"}