Nizoral

Product NDC
55505-192
11-digit product format
555050192
Labeler code
55505
Product ID
55505-192_7afd420a-2022-4666-b027-28d9b15dfd03
Type
HUMAN OTC DRUG
Nonproprietary name
Ketoconazole
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Kramer Laboratories
Application
NDA020310
Marketing category
NDA
Marketing start
2019-01-07
Marketing end
0000-00-00
Substance
KETOCONAZOLE
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55505-192-33ML - Milliliter55505-19281ecddf4-4bef-4009-ab1b-2f271d98232212021-01-08
55505-192-40ML - Milliliter55505-192749b6499-08df-4112-ba24-7a08eaf93f1112021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55505-192NIZORAL (KETOCONAZOLE) SHAMPOO [KRAMER LABORATORIES]7Legacy NDC20250101_63840ff7-d447-4f4e-a05b-1fbed2da8a25.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55505-192-33555050192331 BOTTLE in 1 CARTON (55505-192-33) > 125 mL in 1 BOTTLE1 bottle2019-11-010000-00-00NoNoCurrent
55505-192-40555050192401 BOTTLE in 1 CARTON (55505-192-40) > 200 mL in 1 BOTTLE1 bottle2019-01-070000-00-00NoNoCurrent
55505-192-57555050192572 CARTON in 1 CARTON (55505-192-57) > 1 BOTTLE in 1 CARTON > 200 mL in 1 BOTTLE2 carton2019-11-010000-00-00NoNoCurrent
55505-192-59555050192592 CARTON in 1 CARTON (55505-192-59) > 325 mL in 1 CARTON2 carton2019-11-010000-00-00NoNoCurrent