clotrimazole topical solution usp, 1% (50228-502)

Drug Facts

Product Profile

Brand Name clotrimazole topical solution usp, 1%

Generic Name clotrimazole topical solution usp, 1%

Labeler sciegen pharmaceuticals, inc

Dosage Form SOLUTION

Routes

TOPICAL

Active Ingredients

clotrimazole 10 mg/mL

Manufacturer

ScieGen Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 50228-502

Product ID 50228-502_136855ec-e817-d99c-e063-6394a90a84b1

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 50228502

Hyphenated Format 50228-502

Supplemental Identifiers

RxCUI

309370

UPC

0350228502306 0350228502085 0350228502313

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 (50228-502-08) / 10 mL in 1 BOTTLE
1 BOTTLE in 1 CARTON (50228-502-30) / 30 mL in 1 BOTTLE
1 BOTTLE in 1 CARTON (50228-502-31) / 30 mL in 1 BOTTLE
2 BOTTLE in 1 CARTON (50228-502-61) / 30 mL in 1 BOTTLE

source: ndc

Packages (4)

50228-502-08 1 BOTTLE in 1 CARTON (50228-502-08) / 10 mL in 1 BOTTLE 50228-502-30 1 BOTTLE in 1 CARTON (50228-502-30) / 30 mL in 1 BOTTLE 50228-502-31 1 BOTTLE in 1 CARTON (50228-502-31) / 30 mL in 1 BOTTLE 50228-502-61 2 BOTTLE in 1 CARTON (50228-502-61) / 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": "136855ec-e817-d99c-e063-6394a90a84b1", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0350228502306", "0350228502085", "0350228502313"], "unii": ["G07GZ97H65"], "rxcui": ["309370"], "spl_set_id": ["15368c2a-572f-41fb-a3a1-7b1eb842faa8"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["ScieGen Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50228-502-08)  / 10 mL in 1 BOTTLE", "package_ndc": "50228-502-08", "marketing_start_date": "20231016"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50228-502-30)  / 30 mL in 1 BOTTLE", "package_ndc": "50228-502-30", "marketing_start_date": "20231016"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50228-502-31)  / 30 mL in 1 BOTTLE", "package_ndc": "50228-502-31", "marketing_start_date": "20231016"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (50228-502-61)  / 30 mL in 1 BOTTLE", "package_ndc": "50228-502-61", "marketing_start_date": "20240309"}], "brand_name": "Clotrimazole Topical Solution USP, 1%", "product_id": "50228-502_136855ec-e817-d99c-e063-6394a90a84b1", "dosage_form": "SOLUTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "50228-502", "generic_name": "Clotrimazole Topical Solution USP, 1%", "labeler_name": "ScieGen Pharmaceuticals, 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"}