Clotrimazole Topical Solution USP, 1%

Product NDC
71297-030
11-digit product format
712970030
Labeler code
71297
Product ID
71297-030_4f0966fd-6b7f-84c1-e063-6294a90ab1e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clotrimazole Topical Solution USP, 1%
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Allegis Holdings, LLC
Application
ANDA216569
Marketing category
ANDA
Marketing start
2025-11-12
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
71297-030-02Clotrimazole Topical Solution USP, 1%10 mL in 1 BOTTLESOLUTION103
71297-030-02Clotrimazole 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
71297-030-02ML - Milliliter71297-030c5d56d0c-c940-4867-b935-2020c4cf0c4812026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309370clotrimazole 1 % Topical SolutionPSN529bb597-b291-42fb-b45f-744a55df64f13
309370clotrimazole 10 MG/ML Topical SolutionSCD529bb597-b291-42fb-b45f-744a55df64f13
309370clotrimazole 1 % Topical SolutionSY529bb597-b291-42fb-b45f-744a55df64f13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71297-030-02712970030022 BOTTLE in 1 CARTON (71297-030-02) / 10 mL in 1 BOTTLE2 bottle2025-11-12NoNoCurrent