FDA.reportPublic FDA data

MINOXIDIL 5% (FOR MEN)

Product NDC
58602-608
11-digit product format
586020608
Labeler code
58602
Product ID
58602-608_84225922-895c-4386-b8ef-9b0beb2d1b07
Type
HUMAN OTC DRUG
Nonproprietary name
MINOXIDIL
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Aurohealth LLC
Application
ANDA218616
Marketing category
ANDA
Marketing start
2024-04-22
Substance
MINOXIDIL
Active strength
50 mg/g
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MINOXIDIL 5% (FOR MEN)
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui645146

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-608-01MINOXIDIL 5% (FOR MEN)1 in 1 CARTONAEROSOL, FOAM14
58602-608-01MINOXIDIL 5% (FOR MEN)60 g in 1 CANAEROSOL, FOAM604
58602-608-02MINOXIDIL 5% (FOR MEN)2 in 1 CARTONAEROSOL, FOAM24
58602-608-02MINOXIDIL 5% (FOR MEN)60 g in 1 CANAEROSOL, FOAM604
58602-608-03MINOXIDIL 5% (FOR MEN)3 in 1 CARTONAEROSOL, FOAM34
58602-608-03MINOXIDIL 5% (FOR MEN)60 g in 1 CANAEROSOL, FOAM604
58602-608-04MINOXIDIL 5% (FOR MEN)60 g in 1 CANAEROSOL, FOAM604
58602-608-04MINOXIDIL 5% (FOR MEN)4 in 1 CARTONAEROSOL, FOAM44
58602-608-05MINOXIDIL 5% (FOR MEN)6 in 1 CARTONAEROSOL, FOAM64
58602-608-05MINOXIDIL 5% (FOR MEN)60 g in 1 CANAEROSOL, FOAM604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-608MINOXIDIL 5% (FOR MEN) (MINOXIDIL) AEROSOL, FOAM [AUROHEALTH LLC]1Current NDC, 10 package rows20240504_e6b3b997-cde9-476d-b08c-4d1010456d8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
645146minoxidil 5 % Topical FoamPSNe6b3b997-cde9-476d-b08c-4d1010456d8b4
645146minoxidil 50 MG/ML Topical FoamSCDe6b3b997-cde9-476d-b08c-4d1010456d8b4
645146minoxidil 5 % Topical FoamSYe6b3b997-cde9-476d-b08c-4d1010456d8b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-608-01586020608011 CAN in 1 CARTON (58602-608-01) / 60 g in 1 CAN1 can2024-04-22NoNoCurrent
58602-608-02586020608022 CAN in 1 CARTON (58602-608-02) / 60 g in 1 CAN2 can2024-04-22NoNoCurrent
58602-608-03586020608033 CAN in 1 CARTON (58602-608-03) / 60 g in 1 CAN3 can2024-04-22NoNoCurrent
58602-608-04586020608044 CAN in 1 CARTON (58602-608-04) / 60 g in 1 CAN4 can2024-04-22NoNoCurrent
58602-608-05586020608056 CAN in 1 CARTON (58602-608-05) / 60 g in 1 CAN6 can2024-04-22NoNoCurrent