GROFULLY Womens Hair Regrowth Treatment

Product NDC
70150-006
11-digit product format
701500006
Labeler code
70150
Product ID
70150-006_d65ea212-d155-2013-e053-2a95a90ab2cc
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil 2%
Dosage form
SOLUTION
Route
TOPICAL
Labeler
TTEM, Inc
Application
ANDA078176
Marketing category
ANDA
Marketing start
2022-01-24
Marketing end
0000-00-00
Substance
MINOXIDIL
Active strength
2 g/100mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70150-006-012024-01-30C16284748780-11030e365-5c88-111a-e063-dadaa90a10e2GROFULLY - 2% Minoxidil Topical Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70150-006-01GROFULLY Womens Hair Regrowth Treatment1 in 1 BOXSOLUTION11
70150-006-01GROFULLY Womens Hair Regrowth Treatment60 mL in 1 BOTTLESOLUTION601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70150-006GROFULLY WOMENS HAIR REGROWTH TREATMENT (MINOXIDIL 2%) SOLUTION [TTEM, INC]1Legacy NDC, 2 package rows20220125_d65ea212-d154-2013-e053-2a95a90ab2cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311723minoxidil 2 % Topical SolutionPSNd65ea212-d154-2013-e053-2a95a90ab2cc1
311723minoxidil 20 MG/ML Topical SolutionSCDd65ea212-d154-2013-e053-2a95a90ab2cc1
311723minoxidil 2 % Topical SolutionSYd65ea212-d154-2013-e053-2a95a90ab2cc1
311723minoxidil 2 GM per 100 ML Topical SolutionSYd65ea212-d154-2013-e053-2a95a90ab2cc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70150-006-01701500006011 BOTTLE in 1 BOX (70150-006-01) > 60 mL in 1 BOTTLE1 bottle2022-01-240000-00-00NoNoCurrent