Clotrimazole

Product NDC
68071-2315
11-digit product format
680712315
Labeler code
68071
Product ID
68071-2315_d5902ec4-ca7b-5965-e053-2995a90acd9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA072640
Marketing category
ANDA
Marketing start
1993-08-31
Marketing end
0000-00-00
Substance
CLOTRIMAZOLE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2315-52025-01-30C16284748780-12cef2736-a440-d83d-e063-dadaa90ab31fClotrimazole Cream USP, 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2315-5Clotrimazole15 g in 1 TUBECREAM152
68071-2315-5Clotrimazole1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2315CLOTRIMAZOLE CREAM [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 2 package rows20220115_b6833446-dd2e-0c84-e053-2995a90a6869.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSNb6833446-dd2e-0c84-e053-2995a90a68692
309367clotrimazole 10 MG/ML Topical CreamSCDb6833446-dd2e-0c84-e053-2995a90a68692
309367clotrimazole 1 % Topical CreamSYb6833446-dd2e-0c84-e053-2995a90a68692

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2315-5680712315051 TUBE in 1 CARTON (68071-2315-5) > 15 g in 1 TUBE1 tube2020-12-150000-00-00NoNoCurrent