FDA.reportPublic FDA data

MINOXIDIL 5% (FOR WOMEN)

Product NDC
58602-607
11-digit product format
586020607
Labeler code
58602
Product ID
58602-607_510be93d-eede-433e-a647-2f26f47cddc5
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 WOMEN)
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
58602-607-01MINOXIDIL 5% (FOR WOMEN)1 in 1 CARTONAEROSOL, FOAM14
58602-607-01MINOXIDIL 5% (FOR WOMEN)60 g in 1 CANAEROSOL, FOAM604
58602-607-02MINOXIDIL 5% (FOR WOMEN)2 in 1 CARTONAEROSOL, FOAM24
58602-607-02MINOXIDIL 5% (FOR WOMEN)60 g in 1 CANAEROSOL, FOAM604
58602-607-03MINOXIDIL 5% (FOR WOMEN)60 g in 1 CANAEROSOL, FOAM604
58602-607-03MINOXIDIL 5% (FOR WOMEN)3 in 1 CARTONAEROSOL, FOAM34
58602-607-04MINOXIDIL 5% (FOR WOMEN)4 in 1 CARTONAEROSOL, FOAM44
58602-607-04MINOXIDIL 5% (FOR WOMEN)60 g in 1 CANAEROSOL, FOAM604
58602-607-05MINOXIDIL 5% (FOR WOMEN)6 in 1 CARTONAEROSOL, FOAM64
58602-607-05MINOXIDIL 5% (FOR WOMEN)60 g in 1 CANAEROSOL, FOAM604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-607MINOXIDIL 5% (FOR WOMEN) (MINOXIDIL) AEROSOL, FOAM [AUROHEALTH LLC]1Current NDC, 10 package rows20240504_dbda95f2-11a8-4b2f-af45-b791342fff70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
645146minoxidil 5 % Topical FoamPSNdbda95f2-11a8-4b2f-af45-b791342fff704
645146minoxidil 50 MG/ML Topical FoamSCDdbda95f2-11a8-4b2f-af45-b791342fff704
645146minoxidil 5 % Topical FoamSYdbda95f2-11a8-4b2f-af45-b791342fff704

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-607-01586020607011 CAN in 1 CARTON (58602-607-01) / 60 g in 1 CAN1 can2024-04-22NoNoCurrent
58602-607-02586020607022 CAN in 1 CARTON (58602-607-02) / 60 g in 1 CAN2 can2024-04-22NoNoCurrent
58602-607-03586020607033 CAN in 1 CARTON (58602-607-03) / 60 g in 1 CAN3 can2024-04-22NoNoCurrent
58602-607-04586020607044 CAN in 1 CARTON (58602-607-04) / 60 g in 1 CAN4 can2024-04-22NoNoCurrent
58602-607-05586020607056 CAN in 1 CARTON (58602-607-05) / 60 g in 1 CAN6 can2024-04-22NoNoCurrent