Nizoral

Product NDC
55505-191
11-digit product format
555050191
Labeler code
55505
Product ID
55505-191_681ce4eb-f27d-443d-a6b1-1debb812678c
Type
HUMAN OTC DRUG
Nonproprietary name
Ketoconazole
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Kramer Laboratories
Application
NDA020310
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-01-07
Marketing end
2021-08-01
Substance
KETOCONAZOLE
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55505-191-40ML - Milliliter55505-191fd884180-6a09-4c64-8b36-46031ea06bfb12019-08-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55505-191-3355505019133125 mL in 1 BOTTLE (55505-191-33) 125 ml2019-01-072021-08-01NoNoCurrent
55505-191-40555050191401 BOTTLE in 1 CARTON (55505-191-40) > 200 mL in 1 BOTTLE1 bottle2019-01-072021-08-01NoNoCurrent