Clotrimazole

Product NDC
0472-0220
11-digit product format
004720220
Labeler code
0472
Product ID
0472-0220_2b9ed807-81d1-4e77-9b33-2ef870f0e73d
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
VAGINAL
Labeler
Actavis Pharma, Inc.
Application
ANDA074165
Marketing category
ANDA
Marketing start
2003-07-01
Marketing end
2023-02-28
Substance
CLOTRIMAZOLE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-0220-41GM - Gram0472-022007c8e601-9256-4d0a-bff4-b0a7cb96e84b12013-02-13
0472-0220-63GM - Gram0472-02203567f43b-d2ca-419c-8eda-b9b25afb243b12013-02-13

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
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP.]1
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP.]1
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUCLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP.]1
OCTYLDODECYL STEARATEINACTIVE INGREDIENTK6F16QGO28CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP.]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP.]1
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNCLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP.]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XCLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309368clotrimazole 1 % Vaginal CreamPSN6ea3291c-5b21-4e2b-b114-b491fa33298c9
309368clotrimazole 10 MG/ML Vaginal CreamSCD6ea3291c-5b21-4e2b-b114-b491fa33298c9
309368clotrimazole 1 % Vaginal CreamSY6ea3291c-5b21-4e2b-b114-b491fa33298c9
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
309368clotrimazole 1 % Vaginal CreamPSNefc85b3a-858e-4057-a302-6d9f6cdbd5eb1
309368clotrimazole 10 MG/ML Vaginal CreamSCDefc85b3a-858e-4057-a302-6d9f6cdbd5eb1
309368clotrimazole 1 % Vaginal CreamSYefc85b3a-858e-4057-a302-6d9f6cdbd5eb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0472-0220-41004720220411 TUBE in 1 CARTON (0472-0220-41) > 45 g in 1 TUBE1 tube2003-07-010000-00-00NoNoCurrent
0472-0220-63004720220631 TUBE in 1 CARTON (0472-0220-63) > 45 g in 1 TUBE1 tube2003-07-012023-02-28NoNoCurrent