FDA.reportPublic FDA data

Clotrimazole Topical Solution USP, 1%

Product NDC
71399-0666
11-digit product format
713990666
Labeler code
71399
Product ID
71399-0666_5fbee99b-e93b-4682-9629-98f4f65587fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clotrimazole Topical Solution USP, 1%
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Akron Pharma Inc.
Application
ANDA216569
Marketing category
ANDA
Marketing start
2023-10-16
Substance
CLOTRIMAZOLE
Active strength
10 mg/mL
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clotrimazole Topical Solution USP, 1%
Listing expiration
2026-12-31

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
71399-0666-3Clotrimazole Topical Solution USP, 1%1 in 1 CARTONSOLUTION13
71399-0666-3Clotrimazole Topical Solution USP, 1%30 mL in 1 BOTTLESOLUTION303
71399-0666-6Clotrimazole Topical Solution USP, 1%30 mL in 1 BOTTLESOLUTION303
71399-0666-6Clotrimazole Topical Solution USP, 1%2 in 1 CARTONSOLUTION23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-0666-3ML - Milliliter71399-066643594c1c-2a62-406f-b37f-42262bf4325112024-07-12
71399-0666-6ML - Milliliter71399-06664f6c3b41-3817-4ce9-af78-194247df329212024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-0666CLOTRIMAZOLE TOPICAL SOLUTION USP, 1% SOLUTION [AKRON PHARMA INC.]3Current NDC, 4 package rows20241022_32b968ce-e112-441c-a91f-c62f2f67b57c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309370clotrimazole 1 % Topical SolutionPSN32b968ce-e112-441c-a91f-c62f2f67b57c3
309370clotrimazole 10 MG/ML Topical SolutionSCD32b968ce-e112-441c-a91f-c62f2f67b57c3
309370clotrimazole 1 % Topical SolutionSY32b968ce-e112-441c-a91f-c62f2f67b57c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71399-0666-3713990666031 BOTTLE in 1 CARTON (71399-0666-3) / 30 mL in 1 BOTTLE1 bottle2024-05-04NoNoHistorical
71399-0666-6713990666062 BOTTLE in 1 CARTON (71399-0666-6) / 30 mL in 1 BOTTLE2 bottle2024-03-25NoNoHistorical