Clotrimazole

Product NDC
70000-0729
11-digit product format
700000729
Labeler code
70000
Product ID
70000-0729_2bf37309-fa5f-470b-98c2-e0b078c9e2fd
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
VAGINAL
Labeler
Cardinal Health (Leader) 70000
Application
ANDA074165
Marketing category
ANDA
Marketing start
2025-04-30
Substance
CLOTRIMAZOLE
Active strength
10 mg/g
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/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG07GZ97H65
Rxcui309368

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0729-1Clotrimazole45 g in 1 TUBECREAM451
70000-0729-1Clotrimazole1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0729CLOTRIMAZOLE CREAM [CARDINAL HEALTH (LEADER) 70000]1Current NDC, 2 package rows20250430_4aaae616-179b-40f1-8a39-6a1ddd414070.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309368clotrimazole 1 % Vaginal CreamPSN4aaae616-179b-40f1-8a39-6a1ddd4140701
309368clotrimazole 10 MG/ML Vaginal CreamSCD4aaae616-179b-40f1-8a39-6a1ddd4140701
309368clotrimazole 1 % Vaginal CreamSY4aaae616-179b-40f1-8a39-6a1ddd4140701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0729-1700000729011 TUBE in 1 BOX (70000-0729-1) / 45 g in 1 TUBE1 tube2025-04-30NoNoHistorical