minoxidil topical

Product NDC
59640-000
11-digit product format
596400000
Labeler code
59640
Product ID
59640-000_849cfecb-caff-4634-ab5d-9e944649ffb4
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
SOLUTION
Route
TOPICAL
Labeler
H E B
Application
ANDA075357
Marketing category
ANDA
Marketing start
2021-12-31
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
minoxidil topical
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
59640-000-16minoxidil topical60 mL in 1 BOTTLESOLUTION603
59640-000-16minoxidil topical1 in 1 CARTONSOLUTION13
59640-000-30minoxidil topical60 mL in 1 BOTTLESOLUTION603
59640-000-30minoxidil topical3 in 1 CARTONSOLUTION33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59640-000MINOXIDIL TOPICAL (MINOXIDIL) SOLUTION [H E B]3Current NDC, Legacy NDC, 4 package rows20240718_c9da0a80-2737-4e36-bbef-f7c4ae046ad7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311723minoxidil 2 % Topical SolutionPSNc9da0a80-2737-4e36-bbef-f7c4ae046ad73
311723minoxidil 20 MG/ML Topical SolutionSCDc9da0a80-2737-4e36-bbef-f7c4ae046ad73
311723minoxidil 2 % Topical SolutionSYc9da0a80-2737-4e36-bbef-f7c4ae046ad73
311723minoxidil 2 GM per 100 ML Topical SolutionSYc9da0a80-2737-4e36-bbef-f7c4ae046ad73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59640-000-16596400000161 BOTTLE in 1 CARTON (59640-000-16) / 60 mL in 1 BOTTLE1 bottle2021-12-310000-00-00NoNoCurrent
59640-000-30596400000303 BOTTLE in 1 CARTON (59640-000-30) / 60 mL in 1 BOTTLE3 bottle2022-01-060000-00-00NoNoCurrent