Minoxidil

Product NDC
82796-100
11-digit product format
827960100
Labeler code
82796
Product ID
82796-100_28f9ca10-20c6-b301-e063-6294a90af33c
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
RESTORATION HOLDINGS, LLC
Application
ANDA209074
Marketing category
ANDA
Marketing start
2023-01-01
Substance
MINOXIDIL
Active strength
50 mg/g
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
Brand name suffix
(for Men)
Listing expiration
2026-12-31

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
82796-100-01Minoxidil(for Men)1 in 1 BOXAEROSOL, FOAM17
82796-100-01Minoxidil(for Men)60 g in 1 CONTAINERAEROSOL, FOAM607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82796-100MINOXIDIL (FOR MEN) (MINOXIDIL) AEROSOL, FOAM [RESTORATION HOLDINGS, LLC]7Current NDC, Legacy NDC, 2 package rows20241212_e18223ad-642e-81a5-e053-2a95a90a0752.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
645146minoxidil 5 % Topical FoamPSNe18223ad-642e-81a5-e053-2a95a90a07527
645146minoxidil 50 MG/ML Topical FoamSCDe18223ad-642e-81a5-e053-2a95a90a07527
645146minoxidil 5 % Topical FoamSYe18223ad-642e-81a5-e053-2a95a90a07527

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82796-100-01827960100011 CONTAINER in 1 BOX (82796-100-01) / 60 g in 1 CONTAINER1 container2023-01-010000-00-00NoNoCurrent