FDA.reportPublic FDA data

Clotrimazole

Product NDC
51672-2003
11-digit product format
516722003
Labeler code
51672
Product ID
51672-2003_376636ca-82fd-cf77-e063-6394a90a669d
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
VAGINAL
Labeler
Sun Pharmaceutical Industries, 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2003-6Clotrimazole1 in 1 CARTONCREAM15
51672-2003-6Clotrimazole45 g in 1 TUBECREAM455

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2003-6GM - Gram51672-200357228036-8664-4501-add7-946b4688bf6812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ClotrimazoleACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]1
ClotrimazoleACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
ClotrimazoleACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]1
ClotrimazoleACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]1
cetyl esters waxINACTIVE INGREDIENTD072FFP9GUCLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]1
cetyl esters waxINACTIVE INGREDIENTD072FFP9GUCLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
octyldodecanolINACTIVE INGREDIENT461N1O614YCLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]1
octyldodecanolINACTIVE INGREDIENT461N1O614YCLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MCLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MCLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XCLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XCLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
waterINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2003CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, Legacy NDC, 2 package rows20190226_f7192955-8f8c-45dd-a215-8ac2c1f6444f.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
309368clotrimazole 1 % Vaginal CreamPSN624827d6-dbf8-4f3d-a8c0-c92474cad7de9
309368clotrimazole 10 MG/ML Vaginal CreamSCD624827d6-dbf8-4f3d-a8c0-c92474cad7de9
309368clotrimazole 1 % Vaginal CreamSY624827d6-dbf8-4f3d-a8c0-c92474cad7de9
309368clotrimazole 1 % Vaginal CreamPSNf7192955-8f8c-45dd-a215-8ac2c1f6444f5
309368clotrimazole 10 MG/ML Vaginal CreamSCDf7192955-8f8c-45dd-a215-8ac2c1f6444f5
309368clotrimazole 1 % Vaginal CreamSYf7192955-8f8c-45dd-a215-8ac2c1f6444f5
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
309368clotrimazole 1 % Vaginal CreamPSNb1a02eef-35f0-4d68-8ee4-0a7357bde00c1
309368clotrimazole 10 MG/ML Vaginal CreamSCDb1a02eef-35f0-4d68-8ee4-0a7357bde00c1
309368clotrimazole 1 % Vaginal CreamSYb1a02eef-35f0-4d68-8ee4-0a7357bde00c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-2003-6516722003061 TUBE in 1 CARTON (51672-2003-6) / 45 g in 1 TUBE1 tube1995-12-040000-00-00NoNoCurrent