FDA.reportPublic FDA data

MINOXIDIL

Product NDC
43353-342
Requested package NDC
43353-342-09
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

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
2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
0dada91c-fa1c-4da4-ac0d-e68b017c8604Available on FDA.report

DailyMed Package Descriptions#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-342-09EA - Each43353-342aa0a4504-8164-4009-a01b-dadc9cc9de9412017-12-14

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

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
MINOXIDILMINOXIDILAphena Pharma Solutions - Tennessee, LLC0dada91c-fa1c-4da4-ac0d-e68b017c86042017-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072708
application number: ANDA072708
ndc (package): 43353-342-09
ndc (product): 43353-342
ndc11 (package): 43353034209

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