Clotrimazole

Product NDC
68462-181
11-digit product format
684620181
Labeler code
68462
Product ID
68462-181_23d83b26-b5da-4474-9468-4909134295d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA090219
Marketing category
ANDA
Marketing start
2010-08-04
Substance
CLOTRIMAZOLE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clotrimazole
Listing expiration
2027-12-31

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
68462-181-17Clotrimazole15 g in 1 TUBECREAM158
68462-181-35Clotrimazole30 g in 1 TUBECREAM308
68462-181-47Clotrimazole45 g in 1 TUBECREAM458
68462-181-48Clotrimazole2 in 1 CARTONCREAM28
68462-181-48Clotrimazole45 g in 1 TUBECREAM458

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-181-17GM - Gram68462-181079f8f88-97d0-458a-876e-6a53ab7fd3ea12012-07-24
68462-181-35GM - Gram68462-181892db13f-41ba-47e9-b5d0-b5c8c146116712012-07-24
68462-181-47GM - Gram68462-181b4b331fb-c381-4258-b371-ef65c604e88612012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-181CLOTRIMAZOLE CREAM [GLENMARK PHARMACEUTICALS INC., USA]7Current NDC, Legacy NDC, 5 package rows20181212_f6898117-14f3-42d2-bc0e-d296add3ad70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSNf6898117-14f3-42d2-bc0e-d296add3ad708
309367clotrimazole 10 MG/ML Topical CreamSCDf6898117-14f3-42d2-bc0e-d296add3ad708
309367clotrimazole 1 % Topical CreamSYf6898117-14f3-42d2-bc0e-d296add3ad708
309367clotrimazole 1 % Topical CreamPSN116be3a8-9a57-4b4a-a873-98a4ce83bcf75
309367clotrimazole 10 MG/ML Topical CreamSCD116be3a8-9a57-4b4a-a873-98a4ce83bcf75
309367clotrimazole 1 % Topical CreamSY116be3a8-9a57-4b4a-a873-98a4ce83bcf75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-181-176846201811715 g in 1 TUBE (68462-181-17) 15 g2010-08-040000-00-00NoNoCurrent
68462-181-356846201813530 g in 1 TUBE (68462-181-35) 30 g2010-08-040000-00-00NoNoCurrent
68462-181-476846201814745 g in 1 TUBE (68462-181-47) 45 g2010-08-040000-00-00NoNoCurrent
68462-181-48684620181482 TUBE in 1 CARTON (68462-181-48) / 45 g in 1 TUBE2 tube2010-08-040000-00-00NoNoCurrent