Regoxidine

Product NDC
57483-535
11-digit product format
574830535
Labeler code
57483
Product ID
57483-535_00355b7a-878a-41d4-96bc-dabbc9fb22c6
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Innovus Pharmaceuticals Inc.
Application
ANDA076239
Marketing category
ANDA
Marketing start
2021-05-20
Marketing end
0000-00-00
Substance
MINOXIDIL
Active strength
3 g/60mL
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
57483-535-03Regoxidine60 mL in 1 BOTTLESOLUTION604
57483-535-03Regoxidine3 in 1 CARTONSOLUTION34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57483-535REGOXIDINE (MINOXIDIL) SOLUTION [INNOVUS PHARMACEUTICALS INC.]4Legacy NDC, 2 package rows20241228_34e19938-6df0-468e-8000-661e994d21f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSN34e19938-6df0-468e-8000-661e994d21f24
2548832Regoxidine 5 % Topical SolutionPSN34e19938-6df0-468e-8000-661e994d21f24
2548832minoxidil 50 MG/ML Topical Solution [Regoxidine]SBD34e19938-6df0-468e-8000-661e994d21f24
311724minoxidil 50 MG/ML Topical SolutionSCD34e19938-6df0-468e-8000-661e994d21f24
311724minoxidil 3 GM per 60 ML Topical SolutionSY34e19938-6df0-468e-8000-661e994d21f24
311724minoxidil 5 % Topical SolutionSY34e19938-6df0-468e-8000-661e994d21f24
311724minoxidil 5 GM per 100 ML Topical SolutionSY34e19938-6df0-468e-8000-661e994d21f24
2548832Regoxidine 50 MG/ML Topical SolutionSY34e19938-6df0-468e-8000-661e994d21f24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57483-535-03574830535033 BOTTLE in 1 CARTON (57483-535-03) > 60 mL in 1 BOTTLE3 bottle2021-05-200000-00-00NoNoCurrent