Clotrimazole

Product NDC
51672-1260
11-digit product format
516721260
Labeler code
51672
Product ID
51672-1260_390848b9-e9c6-c3c4-e063-6294a90a5b26
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clotrimazole
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA074580
Marketing category
ANDA
Marketing start
1996-07-29
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
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
51672-1260-3Clotrimazole1 in 1 CARTONSOLUTION14
51672-1260-3Clotrimazole30 mL in 1 BOTTLE, PLASTICSOLUTION304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1260-3ML - Milliliter51672-12608e363d80-bf0a-42fe-a922-703d1b224ec112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ClotrimazoleACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
ClotrimazoleACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQCLOTRIMAZOLE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1260CLOTRIMAZOLE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, Legacy NDC, 2 package rows20170508_3e2041a0-8bef-4be4-b2b1-556446c4a778.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309370clotrimazole 1 % Topical SolutionPSNb67ebafe-0b9d-4fb0-a897-7c9a5691696e5
309370clotrimazole 10 MG/ML Topical SolutionSCDb67ebafe-0b9d-4fb0-a897-7c9a5691696e5
309370clotrimazole 1 % Topical SolutionSYb67ebafe-0b9d-4fb0-a897-7c9a5691696e5
309370clotrimazole 1 % Topical SolutionPSN3e2041a0-8bef-4be4-b2b1-556446c4a7784
309370clotrimazole 10 MG/ML Topical SolutionSCD3e2041a0-8bef-4be4-b2b1-556446c4a7784
309370clotrimazole 1 % Topical SolutionSY3e2041a0-8bef-4be4-b2b1-556446c4a7784

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51672-1260-3516721260031 BOTTLE, PLASTIC in 1 CARTON (51672-1260-3) / 30 mL in 1 BOTTLE, PLASTIC1996-07-290000-00-00NoNoCurrent