FDA.reportPublic FDA data

Minoxidil

Product NDC
0591-5643
11-digit product format
005915643
Labeler code
0591
Product ID
0591-5643_d5ec5f1a-1c30-44a8-93f5-e9e9feef03e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minoxidil
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA071345
Marketing category
ANDA
Marketing start
2009-10-26
Substance
MINOXIDIL
Active strength
10 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
MINOXIDIL10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui197986, 197987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-5643-01Minoxidil100 in 1 BOTTLE, PLASTICTABLET10010
0591-5643-05Minoxidil500 in 1 BOTTLE, PLASTICTABLET50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-5643-01EA - Each0591-564379444291-b043-4a6a-b643-ba153d062a9112012-07-24
0591-5643-05EA - Each0591-5643099379cb-75eb-4bf7-aae3-d5cb921ea9bf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINOXIDILACTIVE INGREDIENT5965120SH1MINOXIDIL TABLET MINOXIDIL TABLET [PHYSICIANS TOTAL CARE, INC.]2
MINOXIDILACTIVE INGREDIENT5965120SH1MINOXIDIL TABLET [WATSON LABORATORIES, INC.]2
MINOXIDILACTIVE MOIETY5965120SH1MINOXIDIL TABLET MINOXIDIL TABLET [PHYSICIANS TOTAL CARE, INC.]2
MINOXIDILACTIVE MOIETY5965120SH1MINOXIDIL TABLET [WATSON LABORATORIES, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMINOXIDIL TABLET MINOXIDIL TABLET [PHYSICIANS TOTAL CARE, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMINOXIDIL TABLET [WATSON LABORATORIES, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMINOXIDIL TABLET MINOXIDIL TABLET [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMINOXIDIL TABLET [WATSON LABORATORIES, INC.]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0MINOXIDIL TABLET MINOXIDIL TABLET [PHYSICIANS TOTAL CARE, INC.]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0MINOXIDIL TABLET [WATSON LABORATORIES, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOXIDIL TABLET MINOXIDIL TABLET [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOXIDIL TABLET [WATSON LABORATORIES, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMINOXIDIL TABLET MINOXIDIL TABLET [PHYSICIANS TOTAL CARE, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMINOXIDIL TABLET [WATSON LABORATORIES, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MINOXIDIL TABLET MINOXIDIL TABLET [PHYSICIANS TOTAL CARE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MINOXIDIL TABLET [WATSON LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5643MINOXIDIL TABLET [ACTAVIS PHARMA, INC.]9Current NDC, Legacy NDC, 2 package rows20250228_ab30461c-f8c8-409d-9e24-d58ed8a34873.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197986minoxidil 10 MG Oral TabletPSNab30461c-f8c8-409d-9e24-d58ed8a3487310
197987minoxidil 2.5 MG Oral TabletPSNab30461c-f8c8-409d-9e24-d58ed8a3487310
197986minoxidil 10 MG Oral TabletSCDab30461c-f8c8-409d-9e24-d58ed8a3487310
197987minoxidil 2.5 MG Oral TabletSCDab30461c-f8c8-409d-9e24-d58ed8a3487310
197986minoxidil 10 MG Oral TabletPSN56274d6f-8439-4ab7-9bb8-a3fc10a264632
197986minoxidil 10 MG Oral TabletPSN9a290e8e-730a-4160-a367-c003bc04a2aa2
197987minoxidil 2.5 MG Oral TabletPSN56274d6f-8439-4ab7-9bb8-a3fc10a264632
197986minoxidil 10 MG Oral TabletSCD56274d6f-8439-4ab7-9bb8-a3fc10a264632
197986minoxidil 10 MG Oral TabletSCD9a290e8e-730a-4160-a367-c003bc04a2aa2
197987minoxidil 2.5 MG Oral TabletSCD56274d6f-8439-4ab7-9bb8-a3fc10a264632
197986minoxidil 10 MG Oral TabletPSNf76f6a05-11f8-48a6-98a3-b1407c2280891
197986minoxidil 10 MG Oral TabletSCDf76f6a05-11f8-48a6-98a3-b1407c2280891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-5643-0100591564301100 TABLET in 1 BOTTLE, PLASTIC (0591-5643-01) 100 tablet2009-10-260000-00-00NoNoCurrent
0591-5643-0500591564305500 TABLET in 1 BOTTLE, PLASTIC (0591-5643-05) 500 tablet2009-10-260000-00-00NoNoCurrent