FDA.reportPublic FDA data

Clotrimazole

Product NDC
51672-1275
11-digit product format
516721275
Labeler code
51672
Product ID
51672-1275_3e748b32-1a66-10b0-e063-6394a90a7321
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA072640
Marketing category
ANDA
Marketing start
1993-08-31
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
Rxcui309367

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1275-1Clotrimazole1 in 1 CARTONCREAM18
51672-1275-1Clotrimazole15 g in 1 TUBECREAM158
51672-1275-2Clotrimazole1 in 1 CARTONCREAM18
51672-1275-2Clotrimazole30 g in 1 TUBECREAM308
51672-1275-6Clotrimazole45 g in 1 TUBECREAM458
51672-1275-6Clotrimazole1 in 1 CARTONCREAM18
51672-1275-7Clotrimazole45 g in 1 TUBECREAM458
51672-1275-7Clotrimazole2 in 1 CARTONCREAM28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1275-1GM - Gram51672-1275593d29e0-4cba-46cc-a57d-5c9bf5e9529312012-07-24
51672-1275-2GM - Gram51672-1275e0172989-2c5a-4d8c-a2f9-4fa2ab03afe312012-07-24
51672-1275-6GM - Gram51672-127518918d69-9395-4a2e-a101-5f77f5ef6fec12012-07-24
51672-1275-7GM - Gram51672-12751c0757eb-637f-4136-b40b-c8282abd88ea12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ClotrimazoleACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
ClotrimazoleACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
cetyl esters waxINACTIVE INGREDIENTD072FFP9GUCLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MCLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
Sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XCLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
waterINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE CREAM [STAT RX USA LLC]1
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE CREAM [STAT RX USA LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE CREAM [STAT RX USA LLC]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE CREAM [STAT RX USA LLC]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUCLOTRIMAZOLE CREAM [STAT RX USA LLC]1
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUCLOTRIMAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
OCTYLDODECYL STEARATEINACTIVE INGREDIENTK6F16QGO28CLOTRIMAZOLE CREAM [STAT RX USA LLC]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCLOTRIMAZOLE CREAM [STAT RX USA LLC]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCLOTRIMAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XCLOTRIMAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XCLOTRIMAZOLE CREAM [STAT RX USA LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE CREAM [STAT RX USA LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1275CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 8 package rows20241222_77883cfd-f13c-40cb-88b2-8f777e1cdce9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSN77883cfd-f13c-40cb-88b2-8f777e1cdce98
309367clotrimazole 10 MG/ML Topical CreamSCD77883cfd-f13c-40cb-88b2-8f777e1cdce98
309367clotrimazole 1 % Topical CreamSY77883cfd-f13c-40cb-88b2-8f777e1cdce98
309367clotrimazole 1 % Topical CreamPSNb6833446-dd2e-0c84-e053-2995a90a68692
309367clotrimazole 1 % Topical CreamPSNc62264a9-cea3-4461-9399-35d8931d38d52
309367clotrimazole 10 MG/ML Topical CreamSCDb6833446-dd2e-0c84-e053-2995a90a68692
309367clotrimazole 10 MG/ML Topical CreamSCDc62264a9-cea3-4461-9399-35d8931d38d52
309367clotrimazole 1 % Topical CreamSYb6833446-dd2e-0c84-e053-2995a90a68692
309367clotrimazole 1 % Topical CreamSYc62264a9-cea3-4461-9399-35d8931d38d52
309367clotrimazole 1 % Topical CreamPSN1fa2664f-955d-4ae1-85ff-186e4aebba491
309367clotrimazole 1 % Topical CreamPSNf003ee1a-a7f6-46b4-8ca7-60bc2ce732f61
309367clotrimazole 10 MG/ML Topical CreamSCD1fa2664f-955d-4ae1-85ff-186e4aebba491
309367clotrimazole 10 MG/ML Topical CreamSCDf003ee1a-a7f6-46b4-8ca7-60bc2ce732f61
309367clotrimazole 1 % Topical CreamSY1fa2664f-955d-4ae1-85ff-186e4aebba491
309367clotrimazole 1 % Topical CreamSYf003ee1a-a7f6-46b4-8ca7-60bc2ce732f61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1275-1516721275011 TUBE in 1 CARTON (51672-1275-1) / 15 g in 1 TUBE1 tube1993-08-310000-00-00NoNoCurrent
51672-1275-2516721275021 TUBE in 1 CARTON (51672-1275-2) / 30 g in 1 TUBE1 tube1993-08-310000-00-00NoNoCurrent
51672-1275-6516721275061 TUBE in 1 CARTON (51672-1275-6) / 45 g in 1 TUBE1 tube1993-08-310000-00-00NoNoCurrent
51672-1275-7516721275072 TUBE in 1 CARTON (51672-1275-7) / 45 g in 1 TUBE2 tube1993-08-310000-00-00NoNoCurrent