FDA.reportPublic FDA data

Clotrimazole Topical Solution USP, 1%

Product NDC
52817-800
11-digit product format
528170800
Labeler code
52817
Product ID
52817-800_48ab26b2-908a-43d1-e063-6394a90a2cb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clotrimazole Topical Solution USP, 1%
Dosage form
SOLUTION
Route
TOPICAL
Labeler
TruPharma LLC
Application
ANDA212281
Marketing category
ANDA
Marketing start
2019-07-25
Substance
CLOTRIMAZOLE
Active strength
10 mg/mL
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clotrimazole Topical Solution USP, 1%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG07GZ97H65
Rxcui309370

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52817-800-30Clotrimazole Topical Solution USP, 1%1 in 1 CARTONSOLUTION15
52817-800-30Clotrimazole Topical Solution USP, 1%30 mL in 1 BOTTLESOLUTION305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-800-30ML - Milliliter52817-80015d28062-8598-4d79-9786-71678bbb14d612019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-800CLOTRIMAZOLE TOPICAL SOLUTION USP, 1% SOLUTION [TRUPHARMA LLC]3Current NDC, Legacy NDC, 2 package rows20231229_1d2354f2-edfd-4be7-9550-760958eb36ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309370clotrimazole 1 % Topical SolutionPSN6a50410d-ef84-4b60-9bec-cf1d1166e461102
309370clotrimazole 10 MG/ML Topical SolutionSCD6a50410d-ef84-4b60-9bec-cf1d1166e461102
309370clotrimazole 1 % Topical SolutionSY6a50410d-ef84-4b60-9bec-cf1d1166e461102
309370clotrimazole 1 % Topical SolutionPSN1d2354f2-edfd-4be7-9550-760958eb36ee5
309370clotrimazole 10 MG/ML Topical SolutionSCD1d2354f2-edfd-4be7-9550-760958eb36ee5
309370clotrimazole 1 % Topical SolutionSY1d2354f2-edfd-4be7-9550-760958eb36ee5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52817-800-30528170800301 BOTTLE in 1 CARTON (52817-800-30) / 30 mL in 1 BOTTLE1 bottle2019-07-250000-00-00NoNoCurrent