clotrimazole topical solution usp, 1% (71297-030)

Drug Facts

Product Profile

Brand Name clotrimazole topical solution usp, 1%

Generic Name clotrimazole topical solution usp, 1%

Labeler allegis holdings, llc

Dosage Form SOLUTION

Routes

TOPICAL

Active Ingredients

clotrimazole 10 mg/mL

Manufacturer

Allegis Holdings, LLC

Identifiers & Regulatory

Product NDC 71297-030

Product ID 71297-030_49ef1f35-49b8-be39-e063-6394a90a9c8d

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA216569

Listing Expiration 2027-12-31

Marketing Start 2025-11-12

Pharmacologic Class

Established (EPC)

azole antifungal [epc]

Chemical Structure

azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71297030

Hyphenated Format 71297-030

Supplemental Identifiers

RxCUI

309370

UPC

0371297030026

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

2 BOTTLE in 1 CARTON (71297-030-02) / 10 mL in 1 BOTTLE

source: ndc

Packages (1)

71297-030-02 2 BOTTLE in 1 CARTON (71297-030-02) / 10 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": "49ef1f35-49b8-be39-e063-6394a90a9c8d", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0371297030026"], "unii": ["G07GZ97H65"], "rxcui": ["309370"], "spl_set_id": ["529bb597-b291-42fb-b45f-744a55df64f1"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Allegis Holdings, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE in 1 CARTON (71297-030-02)  / 10 mL in 1 BOTTLE", "package_ndc": "71297-030-02", "marketing_start_date": "20251112"}], "brand_name": "Clotrimazole Topical Solution USP, 1%", "product_id": "71297-030_49ef1f35-49b8-be39-e063-6394a90a9c8d", "dosage_form": "SOLUTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "71297-030", "generic_name": "Clotrimazole Topical Solution USP, 1%", "labeler_name": "Allegis Holdings, LLC", "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": "20251112", "listing_expiration_date": "20271231"}