5% Minoxidil Topical Solution

Product NDC
49539-001
11-digit product format
495390001
Labeler code
49539
Product ID
49539-001_f1e964cb-33eb-61b4-e053-2a95a90a7183
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil
Dosage form
SOLUTION
Route
TOPICAL
Labeler
AVACOR PRODUCTS, LLC
Application
ANDA076239
Marketing category
ANDA
Marketing start
2019-04-01
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
49539-001-012025-01-30C16284748780-12cef2736-6225-d83d-e063-dadaa90ab31fAVACOR - 5% Minoxidil Topical Solution, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49539-001-015% Minoxidil Topical Solution60 mL in 1 BOTTLESOLUTION602
49539-001-015% Minoxidil Topical Solution3 in 1 CARTONSOLUTION32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49539-0015% MINOXIDIL TOPICAL SOLUTION (MINOXIDIL) SOLUTION [AVACOR PRODUCTS, LLC]2Legacy NDC, 2 package rows20230111_857b9644-009b-6f66-e053-2991aa0af011.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSN857b9644-009b-6f66-e053-2991aa0af0112
311724minoxidil 50 MG/ML Topical SolutionSCD857b9644-009b-6f66-e053-2991aa0af0112
311724minoxidil 3 GM per 60 ML Topical SolutionSY857b9644-009b-6f66-e053-2991aa0af0112
311724minoxidil 5 % Topical SolutionSY857b9644-009b-6f66-e053-2991aa0af0112
311724minoxidil 5 GM per 100 ML Topical SolutionSY857b9644-009b-6f66-e053-2991aa0af0112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49539-001-01495390001013 BOTTLE in 1 CARTON (49539-001-01) > 60 mL in 1 BOTTLE3 bottle2019-04-010000-00-00NoNoCurrent