Regoxidine

Product NDC
57483-542
11-digit product format
574830542
Labeler code
57483
Product ID
57483-542_c311118f-5db6-4d28-a94b-5415ea14bbde
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Innovus Pharmaceuticals Inc.
Application
ANDA078176
Marketing category
ANDA
Marketing start
2021-04-19
Marketing end
0000-00-00
Substance
MINOXIDIL
Active strength
2 g/100mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57483-542-03Regoxidine60 mL in 1 BOTTLESOLUTION605
57483-542-03Regoxidine3 in 1 CARTONSOLUTION35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57483-542REGOXIDINE (MINOXIDIL) SOLUTION [INNOVUS PHARMACEUTICALS INC.]5Legacy NDC, 2 package rows20241230_5842b4b7-674c-42f5-88ce-1ac629303bd4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311723minoxidil 2 % Topical SolutionPSN5842b4b7-674c-42f5-88ce-1ac629303bd45
2538832Regoxidine 2 % Topical SolutionPSN5842b4b7-674c-42f5-88ce-1ac629303bd45
2538832minoxidil 20 MG/ML Topical Solution [Regoxidine]SBD5842b4b7-674c-42f5-88ce-1ac629303bd45
311723minoxidil 20 MG/ML Topical SolutionSCD5842b4b7-674c-42f5-88ce-1ac629303bd45
311723minoxidil 2 % Topical SolutionSY5842b4b7-674c-42f5-88ce-1ac629303bd45
311723minoxidil 2 GM per 100 ML Topical SolutionSY5842b4b7-674c-42f5-88ce-1ac629303bd45
2538832Regoxidine 2 % Topical SolutionSY5842b4b7-674c-42f5-88ce-1ac629303bd45
2538832Regoxidine 20 MG/ML Topical SolutionSY5842b4b7-674c-42f5-88ce-1ac629303bd45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57483-542-03574830542033 BOTTLE in 1 CARTON (57483-542-03) > 60 mL in 1 BOTTLE3 bottle2021-04-190000-00-00NoNoCurrent