Clotrimazole

Product NDC
50090-0614
11-digit product format
500900614
Labeler code
50090
Product ID
50090-0614_dac23c28-1694-4482-9fdb-492595e970e0
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
VAGINAL
Labeler
A-S Medication Solutions
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clotrimazole
Listing expiration
2027-12-31

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
50090-0614-02023-02-07C16284748780-1f386c64a-446e-0266-e053-dadaa90a7c1aClotrimazole Vaginal Cream USP 1%
50090-0614-02023-01-30C16284748780-1f386c64a-446e-0266-e053-dadaa90a7c1aClotrimazole Vaginal Cream USP 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0614-0Clotrimazole1 in 1 CARTONCREAM114
50090-0614-0Clotrimazole45 g in 1 TUBECREAM4514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0614-0GM - Gram50090-0614c27a8898-36fb-4e77-b5f0-e80728fafe2212024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0614CLOTRIMAZOLE CREAM [A-S MEDICATION SOLUTIONS]12Current NDC, Legacy NDC, 2 package rows20230208_bac80746-5cc3-4910-a0af-d43b8242acc6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309368clotrimazole 1 % Vaginal CreamPSNbac80746-5cc3-4910-a0af-d43b8242acc614
309368clotrimazole 10 MG/ML Vaginal CreamSCDbac80746-5cc3-4910-a0af-d43b8242acc614
309368clotrimazole 1 % Vaginal CreamSYbac80746-5cc3-4910-a0af-d43b8242acc614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0614-0500900614001 TUBE in 1 CARTON (50090-0614-0) / 45 g in 1 TUBE1 tube2014-11-280000-00-00NoNoCurrent