Roots Professional - Topical Solution Hair Regrowth Treatment

Product NDC
73359-002
11-digit product format
733590002
Labeler code
73359
Product ID
73359-002_f1e962be-e772-cd46-e053-2995a90a1c83
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil 5%
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Roots Hair Club, LLC
Application
ANDA076239
Marketing category
ANDA
Marketing start
2019-09-11
Marketing end
0000-00-00
Substance
MINOXIDIL
Active strength
5 g/100mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73359-002-012025-01-30C16284748780-12cef2736-af9f-d83d-e063-dadaa90ab31fRoots Professional - 5% Minoxidil Topical Solution Hair Regrowth Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73359-002-01Roots Professional - Topical Solution Hair Regrowth Treatment1 in 1 BOXSOLUTION12
73359-002-01Roots Professional - Topical Solution Hair Regrowth Treatment60 mL in 1 BOTTLESOLUTION602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73359-002ROOTS PROFESSIONAL - TOPICAL SOLUTION HAIR REGROWTH TREATMENT (MINOXIDIL 5%) SOLUTION [ROOTS HAIR CLUB, LLC]2Legacy NDC, 2 package rows20230111_92507885-2623-205c-e053-2995a90a1592.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSN92507885-2623-205c-e053-2995a90a15922
311724minoxidil 50 MG/ML Topical SolutionSCD92507885-2623-205c-e053-2995a90a15922
311724minoxidil 3 GM per 60 ML Topical SolutionSY92507885-2623-205c-e053-2995a90a15922
311724minoxidil 5 % Topical SolutionSY92507885-2623-205c-e053-2995a90a15922
311724minoxidil 5 GM per 100 ML Topical SolutionSY92507885-2623-205c-e053-2995a90a15922

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73359-002-01733590002011 BOTTLE in 1 BOX (73359-002-01) > 60 mL in 1 BOTTLE1 bottle2019-09-110000-00-00NoNoCurrent