FDA.reportPublic FDA data

Ketoconazole

Product NDC
51407-279
11-digit product format
514070279
Labeler code
51407
Product ID
51407-279_3996f6a2-d5c7-ff54-e063-6294a90a12b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoconazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA075638
Marketing category
ANDA
Marketing start
2002-12-18
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
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-279-15Ketoconazole1 in 1 CARTONCREAM14
51407-279-15Ketoconazole15 g in 1 TUBECREAM154
51407-279-30Ketoconazole30 g in 1 TUBECREAM304
51407-279-30Ketoconazole1 in 1 CARTONCREAM14
51407-279-60Ketoconazole60 g in 1 TUBECREAM604
51407-279-60Ketoconazole1 in 1 CARTONCREAM14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-279-15GM - Gram51407-2799e871c30-e44e-4ae2-90e5-542e39ddeb5412020-01-03
51407-279-30GM - Gram51407-279505944e2-9c6b-4d8f-856b-4994badbb13712020-01-03
51407-279-60GM - Gram51407-2799509af79-965f-49b3-bc0c-7047c4fa8e8112020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-279KETOCONAZOLE CREAM [GOLDEN STATE MEDICAL SUPPLY, INC.]3Current NDC, Legacy NDC, 6 package rows20240404_3e3cde4b-939f-4837-9920-bb6bb8416bd6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
203088ketoconazole 2 % Topical CreamPSN3e3cde4b-939f-4837-9920-bb6bb8416bd64
203088ketoconazole 20 MG/ML Topical CreamSCD3e3cde4b-939f-4837-9920-bb6bb8416bd64
203088ketoconazole 2 % Topical CreamSY3e3cde4b-939f-4837-9920-bb6bb8416bd64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-279-15514070279151 TUBE in 1 CARTON (51407-279-15) / 15 g in 1 TUBE1 tube2020-02-090000-00-00NoNoCurrent
51407-279-30514070279301 TUBE in 1 CARTON (51407-279-30) / 30 g in 1 TUBE1 tube2020-02-090000-00-00NoNoCurrent
51407-279-60514070279601 TUBE in 1 CARTON (51407-279-60) / 60 g in 1 TUBE1 tube2020-02-090000-00-00NoNoCurrent