Leader Minoxidil

Product NDC
70000-0653
11-digit product format
700000653
Labeler code
70000
Product ID
70000-0653_cf5fb0e6-c973-4bd4-a03e-96822c7585a7
Type
HUMAN OTC DRUG
Nonproprietary name
minoxidil
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
ANDA075598
Marketing category
ANDA
Marketing start
2024-03-04
Substance
MINOXIDIL
Active strength
5 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
MINOXIDIL5 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui311724

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0653-1Leader Minoxidil60 mL in 1 BOTTLE, DROPPERSOLUTION602
70000-0653-1Leader Minoxidil3 in 1 CARTONSOLUTION32
70000-0653-2Leader Minoxidil60 mL in 1 BOTTLE, DROPPERSOLUTION602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0653LEADER MINOXIDIL (MINOXIDIL) SOLUTION [CARDINAL HEALTH 110, LLC. DBA LEADER]2Current NDC, 3 package rows20240307_fbb17735-6c1f-44d6-865b-feec83a66b69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSNfbb17735-6c1f-44d6-865b-feec83a66b692
311724minoxidil 50 MG/ML Topical SolutionSCDfbb17735-6c1f-44d6-865b-feec83a66b692
311724minoxidil 3 GM per 60 ML Topical SolutionSYfbb17735-6c1f-44d6-865b-feec83a66b692
311724minoxidil 5 % Topical SolutionSYfbb17735-6c1f-44d6-865b-feec83a66b692
311724minoxidil 5 GM per 100 ML Topical SolutionSYfbb17735-6c1f-44d6-865b-feec83a66b692

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0653-1700000653013 BOTTLE, DROPPER in 1 CARTON (70000-0653-1) / 60 mL in 1 BOTTLE, DROPPER2024-03-04NoNoHistorical
70000-0653-27000006530260 mL in 1 BOTTLE, DROPPER (70000-0653-2) 60 ml2024-03-04NoNoHistorical