KERANIQUE HAIR REGROWTH TREATMENT FOR WOMEN

Product NDC
65121-578
11-digit product format
651210578
Labeler code
65121
Product ID
65121-578_e8918aa5-6c0f-5f77-e053-2995a90acddc
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil 2%
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Pure Source, LLC
Application
ANDA078176
Marketing category
ANDA
Marketing start
2022-09-13
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
65121-578-042024-01-30C16284748780-11030e365-0a2e-111a-e063-dadaa90a10e2KERANIQUE HAIR REGROWTH TREATMENT FOR WOMEN- minoxidil 2% spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65121-578-04KERANIQUE HAIR REGROWTH TREATMENT FOR WOMEN60 mL in 1 BOTTLESOLUTION601
65121-578-04KERANIQUE HAIR REGROWTH TREATMENT FOR WOMEN4 in 1 BOXSOLUTION41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65121-578KERANIQUE HAIR REGROWTH TREATMENT FOR WOMEN (MINOXIDIL 2%) SOLUTION [PURE SOURCE, LLC]1Legacy NDC, 2 package rows20220914_e8918aa5-6c0e-5f77-e053-2995a90acddc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311723minoxidil 2 % Topical SolutionPSNe8918aa5-6c0e-5f77-e053-2995a90acddc1
311723minoxidil 20 MG/ML Topical SolutionSCDe8918aa5-6c0e-5f77-e053-2995a90acddc1
311723minoxidil 2 % Topical SolutionSYe8918aa5-6c0e-5f77-e053-2995a90acddc1
311723minoxidil 2 GM per 100 ML Topical SolutionSYe8918aa5-6c0e-5f77-e053-2995a90acddc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65121-578-04651210578044 BOTTLE in 1 BOX (65121-578-04) > 60 mL in 1 BOTTLE4 bottle2022-09-130000-00-00NoNoCurrent