MINOXIDIL

Product NDC
43353-342
11-digit product format
433530342
Labeler code
43353
Product ID
43353-342_adc9595c-1b82-45f5-a679-ecf843d8baf2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
minoxidil
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA072708
Marketing category
ANDA
Marketing start
2013-08-01
Substance
MINOXIDIL
Active strength
2.5 mg/1
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
MINOXIDIL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui197987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-342-09MINOXIDIL9000 in 1 BOTTLETABLET90001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-342MINOXIDIL (MINOXIDIL) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 1 package rows20171003_0dada91c-fa1c-4da4-ac0d-e68b017c8604.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197987minoxidil 2.5 MG Oral TabletPSN0dada91c-fa1c-4da4-ac0d-e68b017c86041
197987minoxidil 2.5 MG Oral TabletSCD0dada91c-fa1c-4da4-ac0d-e68b017c86041

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-342-09433530342099000 TABLET in 1 BOTTLE (43353-342-09) 9000 tablet2017-06-020000-00-00NoNoCurrent