FDA.reportPublic FDA data

Ketoconazole

Product NDC
68071-3512
11-digit product format
680713512
Labeler code
68071
Product ID
68071-3512_2d04d27d-6b6d-e729-e063-6394a90ab60b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoconazole Cream, 2%
Dosage form
CREAM
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA212443
Marketing category
ANDA
Marketing start
2021-05-27
Substance
KETOCONAZOLE
Active strength
20 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ketoconazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOCONAZOLE20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR9400W927I
Rxcui203088

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5Product name220250331
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2Product name220211209
8bc3781f-20ed-678b-44a7-a981e693c65fProduct name220211209
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3512-52025-02-01C16284748780-12cef2736-7527-d83d-e063-dadaa90ab31fKETOCONAZOLE CREAM Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3512-5Ketoconazole15 g in 1 TUBECREAM152
68071-3512-5Ketoconazole15 in 1 CARTONCREAM152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3512KETOCONAZOLE (KETOCONAZOLE CREAM, 2%) CREAM [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 2 package rows20250202_05f9938a-1577-adec-e063-6294a90af349.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
203088ketoconazole 2 % Topical CreamPSN05f9938a-1577-adec-e063-6294a90af3492
203088ketoconazole 20 MG/ML Topical CreamSCD05f9938a-1577-adec-e063-6294a90af3492
203088ketoconazole 2 % Topical CreamSY05f9938a-1577-adec-e063-6294a90af3492

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3512-56807135120515 TUBE in 1 CARTON (68071-3512-5) / 15 g in 1 TUBE15 tube2023-09-02NoNoHistorical