FDA.reportPublic FDA data

MINOXIDIL

Product NDC
42291-618
Requested package NDC
42291-618-01
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

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5965120SH1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197986Internal RxNorm lookup
197987Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
02d7399f-94cc-f718-f214-587301edd138Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MINOXIDILMINOXIDILAvKARE02d7399f-94cc-f718-f214-587301edd1382026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072708
application number: ANDA072708
ndc (package): 42291-618-01
ndc (product): 42291-618
ndc11 (package): 42291061801
MINOXIDILMINOXIDILAphena Pharma Solutions - Tennessee, LLC0dada91c-fa1c-4da4-ac0d-e68b017c86042017-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072708
application number: ANDA072708

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