MINOXIDIL

Product NDC
42291-618
11-digit product format
422910618
Labeler code
42291
Product ID
42291-618_48e97f58-ac9b-0967-e063-6294a90a26a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
minoxidil
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MINOXIDIL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui197986, 197987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-618-01MINOXIDIL100 in 1 BOTTLETABLET10013
42291-618-90MINOXIDIL90 in 1 BOTTLETABLET9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-618-01EA - Each42291-618aec2efcf-420c-4fb1-a0b3-9b75cb2ae97512014-09-03
42291-618-10EA - Each42291-618125ee2dd-2559-4c6d-bdd8-740f7306599412013-10-17
42291-618-90EA - Each42291-618e56a3313-bf5a-418e-b860-612fde52cc9012013-10-17

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
42291-618MINOXIDIL TABLET [AVKARE]12Current NDC, Legacy 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
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
42291-618-0142291061801100 TABLET in 1 BOTTLE (42291-618-01) 100 tablet2013-08-010000-00-00NoNoCurrent
42291-618-904229106189090 in 1 BOTTLEHistorical