MINOXIDIL

Product NDC
42291-619
11-digit product format
422910619
Labeler code
42291
Product ID
42291-619_d57e53ae-531e-964e-e053-2a95a90a2e0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
minoxidil
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA072709
Marketing category
ANDA
Marketing start
2013-08-01
Marketing end
0000-00-00
Substance
MINOXIDIL
Active strength
10 mg/1
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-619-01MINOXIDIL100 in 1 BOTTLETABLET10013
42291-619-90MINOXIDIL90 in 1 BOTTLETABLET9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-619-01EA - Each42291-619aa0a976a-a209-4adc-b724-2162ba27f3ca12014-09-03
42291-619-10EA - Each42291-6198d4f171b-a7a5-44b5-aec8-57483c43547e12013-10-17
42291-619-90EA - Each42291-6193f487993-d01d-439a-a08c-6317270b227712013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
minoxidilACTIVE INGREDIENT5965120SH1MINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.]2
minoxidilACTIVE MOIETY5965120SH1MINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.]2
Anhydrous LactoseINACTIVE INGREDIENT3SY5LH9PMKMINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30MINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4MINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.]2
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2MINOXIDIL (MINOXIDIL) TABLET [AVKARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-619MINOXIDIL TABLET [AVKARE]12Legacy NDC, 2 package rows20250112_02d7399f-94cc-f718-f214-587301edd138.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197986minoxidil 10 MG Oral TabletPSN02d7399f-94cc-f718-f214-587301edd13813
197987minoxidil 2.5 MG Oral TabletPSN02d7399f-94cc-f718-f214-587301edd13813
197986minoxidil 10 MG Oral TabletSCD02d7399f-94cc-f718-f214-587301edd13813
197987minoxidil 2.5 MG Oral TabletSCD02d7399f-94cc-f718-f214-587301edd13813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-619-0142291061901100 TABLET in 1 BOTTLE (42291-619-01) 100 tablet2013-08-010000-00-00NoNoCurrent
42291-619-904229106199090 in 1 BOTTLEHistorical