Hair Regrowth Treatment

Product NDC
82269-607
11-digit product format
822690607
Labeler code
82269
Product ID
82269-607_f1e201e6-7dc7-4697-9e56-a096c5fd338a
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Seiseidou America, Inc.
Application
ANDA075518
Marketing category
ANDA
Marketing start
2021-10-15
Substance
MINOXIDIL
Active strength
50 mg/mL
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
Hair Regrowth Treatment
Brand name suffix
Extra Strength for Men
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui311724

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82269-607-02Hair Regrowth TreatmentExtra Strength for Men1 in 1 CARTONSOLUTION13
82269-607-02Hair Regrowth TreatmentExtra Strength for Men60 mL in 1 BOTTLE, DROPPERSOLUTION603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82269-607HAIR REGROWTH TREATMENT EXTRA STRENGTH FOR MEN (MINOXIDIL) SOLUTION [SEISEIDOU AMERICA, INC.]2Current NDC, Legacy NDC, 2 package rows20221109_1bcb9934-861c-405a-948a-3e4cdd13246d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSN1bcb9934-861c-405a-948a-3e4cdd13246d3
311724minoxidil 50 MG/ML Topical SolutionSCD1bcb9934-861c-405a-948a-3e4cdd13246d3
311724minoxidil 3 GM per 60 ML Topical SolutionSY1bcb9934-861c-405a-948a-3e4cdd13246d3
311724minoxidil 5 % Topical SolutionSY1bcb9934-861c-405a-948a-3e4cdd13246d3
311724minoxidil 5 GM per 100 ML Topical SolutionSY1bcb9934-861c-405a-948a-3e4cdd13246d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82269-607-02822690607021 BOTTLE, DROPPER in 1 CARTON (82269-607-02) / 60 mL in 1 BOTTLE, DROPPER2021-10-150000-00-00NoNoCurrent