clotrimazole topical solution usp, 1% (52817-800)

Drug Facts

Product Profile

Brand Name clotrimazole topical solution usp, 1%

Generic Name clotrimazole topical solution usp, 1%

Labeler trupharma llc

Dosage Form SOLUTION

Routes

TOPICAL

Active Ingredients

clotrimazole 10 mg/mL

Manufacturer

TruPharma LLC

Identifiers & Regulatory

Product NDC 52817-800

Product ID 52817-800_48ab26b2-908a-43d1-e063-6394a90a2cb5

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA212281

Listing Expiration 2027-12-31

Marketing Start 2019-07-25

Pharmacologic Class

Established (EPC)

azole antifungal [epc]

Chemical Structure

azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52817800

Hyphenated Format 52817-800

Supplemental Identifiers

RxCUI

309370

UPC

0352817800305

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 ANDA212281 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

10 mg/mL

source: ndc

Packaging

1 BOTTLE in 1 CARTON (52817-800-30) / 30 mL in 1 BOTTLE

source: ndc

Packages (1)

52817-800-30 1 BOTTLE in 1 CARTON (52817-800-30) / 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": "48ab26b2-908a-43d1-e063-6394a90a2cb5", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0352817800305"], "unii": ["G07GZ97H65"], "rxcui": ["309370"], "spl_set_id": ["1d2354f2-edfd-4be7-9550-760958eb36ee"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["TruPharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (52817-800-30)  / 30 mL in 1 BOTTLE", "package_ndc": "52817-800-30", "marketing_start_date": "20190725"}], "brand_name": "Clotrimazole Topical Solution USP, 1%", "product_id": "52817-800_48ab26b2-908a-43d1-e063-6394a90a2cb5", "dosage_form": "SOLUTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "52817-800", "generic_name": "Clotrimazole Topical Solution USP, 1%", "labeler_name": "TruPharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clotrimazole Topical Solution USP, 1%", "active_ingredients": [{"name": "CLOTRIMAZOLE", "strength": "10 mg/mL"}], "application_number": "ANDA212281", "marketing_category": "ANDA", "marketing_start_date": "20190725", "listing_expiration_date": "20271231"}