Clotrimazole

Product NDC
68071-4026
11-digit product format
680714026
Labeler code
68071
Product ID
68071-4026_1d7a4d76-63d1-8f28-e063-6394a90aa165
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
VAGINAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA072641
Marketing category
ANDA
Marketing start
1995-12-04
Substance
CLOTRIMAZOLE
Active strength
1 g/100g
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
CLOTRIMAZOLE1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG07GZ97H65
Rxcui309368

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4026-42022-02-07C16284748780-1d6a99b39-c576-a426-e053-dadaa90af4c2Clotrimazole
68071-4026-42022-01-28C16284748780-1d6a99b39-c576-a426-e053-dadaa90af4c2Clotrimazole

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4026-4Clotrimazole1 in 1 CARTONCREAM13
68071-4026-4Clotrimazole45 g in 1 TUBECREAM453

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4026CLOTRIMAZOLE CREAM [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 2 package rows20240719_ab0e14b8-8c64-435c-e053-2a95a90acfba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309368clotrimazole 1 % Vaginal CreamPSNab0e14b8-8c64-435c-e053-2a95a90acfba3
309368clotrimazole 10 MG/ML Vaginal CreamSCDab0e14b8-8c64-435c-e053-2a95a90acfba3
309368clotrimazole 1 % Vaginal CreamSYab0e14b8-8c64-435c-e053-2a95a90acfba3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4026-4680714026041 TUBE in 1 CARTON (68071-4026-4) / 45 g in 1 TUBE1 tube2020-07-220000-00-00NoNoCurrent