Clotrimazole

Product NDC
76413-327
11-digit product format
764130327
Labeler code
76413
Product ID
76413-327_228ef141-0a88-4dba-b7b8-2fdd2eb18572
Type
HUMAN OTC DRUG
Nonproprietary name
clotrimazole
Dosage form
CREAM
Route
VAGINAL
Labeler
Central Texas Community Health Centers
Application
ANDA074165
Marketing category
ANDA
Marketing start
2003-08-12
Marketing end
0000-00-00
Substance
CLOTRIMAZOLE
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2019-12-31
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
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76413-327-302020-01-31C16284748780-19d75b9d1-11f1-f424-e053-dadaa90a57ceClotrimazole Vaginal Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76413-327-30Clotrimazole28 g in 1 TUBECREAM281
76413-327-30Clotrimazole1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76413-327CLOTRIMAZOLE CREAM [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]1Legacy NDC, 2 package rows20161116_ef0b0fca-40c4-4bb6-8a0a-9c3ff717866f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309368clotrimazole 1 % Vaginal CreamPSNef0b0fca-40c4-4bb6-8a0a-9c3ff717866f1
309368clotrimazole 10 MG/ML Vaginal CreamSCDef0b0fca-40c4-4bb6-8a0a-9c3ff717866f1
309368clotrimazole 1 % Vaginal CreamSYef0b0fca-40c4-4bb6-8a0a-9c3ff717866f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
76413-327-307641303273028 g in 1 TUBE28 gHistorical