FDA.reportPublic FDA data

Clotrimazole

Product NDC
68788-0169
11-digit product format
687880169
Labeler code
68788
Product ID
68788-0169_68f02939-7202-4c7f-b4d3-ae44d682d678
Type
HUMAN OTC DRUG
Nonproprietary name
clotrimazole
Dosage form
CREAM
Route
VAGINAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA074165
Marketing category
ANDA
Marketing start
2013-08-06
Marketing end
0000-00-00
Substance
CLOTRIMAZOLE
Active strength
1 g/100g
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68788-0169-42020-01-31C16284748780-19d75b9d0-5f56-f424-e053-dadaa90a57ceClotrimazole Vaginal Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-0169-4Clotrimazole45 g in 1 TUBECREAM454
68788-0169-4Clotrimazole1 in 1 CARTONCREAM14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUCLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
OCTYLDODECYL STEARATEINACTIVE INGREDIENTK6F16QGO28CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNCLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XCLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-0169CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]4Legacy NDC, 2 package rows20170616_0e696120-8cc9-40f1-a03e-9c681b3790b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309368clotrimazole 1 % Vaginal CreamPSN0e696120-8cc9-40f1-a03e-9c681b3790b24
309368clotrimazole 10 MG/ML Vaginal CreamSCD0e696120-8cc9-40f1-a03e-9c681b3790b24
309368clotrimazole 1 % Vaginal CreamSY0e696120-8cc9-40f1-a03e-9c681b3790b24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68788-0169-46878801690445 g in 1 TUBE45 gHistorical