Clotrimazole

Product NDC
49348-793
11-digit product format
493480793
Labeler code
49348
Product ID
49348-793_c2c4de79-b6f4-4bbe-9c40-35acb45419a7
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
VAGINAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA074165
Marketing category
ANDA
Marketing start
1993-07-19
Marketing end
2026-12-31
Substance
CLOTRIMAZOLE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clotrimazole

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG07GZ97H65
Rxcui309368

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
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-793-76Clotrimazole1 in 1 CARTONCREAM112
49348-793-76Clotrimazole45 g in 1 TUBECREAM4512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-793-76GM - Gram49348-79382e7ae08-d470-4b18-9759-b050016a79c212012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-793CLOTRIMAZOLE CREAM [STRATEGIC SOURCING SERVICES LLC]11Current NDC, Legacy NDC, 2 package rows20241122_de3b6b64-dfa5-4abd-ba43-4ab59b4c2284.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309368clotrimazole 1 % Vaginal CreamPSNde3b6b64-dfa5-4abd-ba43-4ab59b4c228412
309368clotrimazole 10 MG/ML Vaginal CreamSCDde3b6b64-dfa5-4abd-ba43-4ab59b4c228412
309368clotrimazole 1 % Vaginal CreamSYde3b6b64-dfa5-4abd-ba43-4ab59b4c228412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-793-76493480793761 TUBE in 1 CARTON (49348-793-76) / 45 g in 1 TUBE1 tube1993-07-192026-12-31NoNoCurrent