Leader minoxidil

Product NDC
70000-0728
11-digit product format
700000728
Labeler code
70000
Product ID
70000-0728_6e34c9c1-a520-4617-9a4b-cea18e6823b2
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
ANDA075357
Marketing category
ANDA
Marketing start
2025-04-24
Substance
MINOXIDIL
Active strength
2 g/100mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Leader minoxidil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL2 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui311723

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0728-1Leader minoxidil3 in 1 CARTONSOLUTION32
70000-0728-2Leader minoxidil60 mL in 1 BOTTLE, DROPPERSOLUTION602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0728LEADER MINOXIDIL (MINOXIDIL) SOLUTION [CARDINAL HEALTH 110, LLC. DBA LEADER]2Current NDC, 2 package rows20250428_4955e5f1-b893-4a83-8fca-b199c67b1fb4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311723minoxidil 2 % Topical SolutionPSN4955e5f1-b893-4a83-8fca-b199c67b1fb42
311723minoxidil 20 MG/ML Topical SolutionSCD4955e5f1-b893-4a83-8fca-b199c67b1fb42
311723minoxidil 2 % Topical SolutionSY4955e5f1-b893-4a83-8fca-b199c67b1fb42
311723minoxidil 2 GM per 100 ML Topical SolutionSY4955e5f1-b893-4a83-8fca-b199c67b1fb42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0728-1700000728013 BOTTLE, DROPPER in 1 CARTON (70000-0728-1) / 60 mL in 1 BOTTLE, DROPPER (70000-0728-2) 2025-04-24NoNoHistorical
70000-0728-27000007280260 mL in 1 BOTTLE, DROPPER60 mlHistorical