Minoxidil

Product NDC
49884-257
11-digit product format
498840257
Labeler code
49884
Product ID
49884-257_d387cf20-4627-4429-8408-f240ace9df72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minoxidil
Dosage form
TABLET
Route
ORAL
Labeler
Endo USA, Inc.
Application
ANDA071839
Marketing category
ANDA
Marketing start
1988-11-14
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL10 mg/1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-257-01Minoxidil100 in 1 BOTTLETABLET1009
49884-257-05Minoxidil500 in 1 BOTTLETABLET5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-257-01EA - Each49884-2578335f65e-b2da-40e9-9017-d687d4db81a112012-07-24
49884-257-05EA - Each49884-257e284196a-0149-48a7-995e-418d621ad25112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINOXIDILACTIVE INGREDIENT5965120SH1MINOXIDIL TABLET [PAR PHARMACEUTICAL INC]6
MINOXIDILACTIVE MOIETY5965120SH1MINOXIDIL TABLET [PAR PHARMACEUTICAL INC]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMINOXIDIL TABLET [PAR PHARMACEUTICAL INC]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMINOXIDIL TABLET [PAR PHARMACEUTICAL INC]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOXIDIL TABLET [PAR PHARMACEUTICAL INC]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MINOXIDIL TABLET [PAR PHARMACEUTICAL INC]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMINOXIDIL TABLET [PAR PHARMACEUTICAL INC]6
MINOXIDILACTIVE INGREDIENT5965120SH1MINOXIDIL TABLET [AMERICAN HEALTH PACKAGING]3
MINOXIDILACTIVE MOIETY5965120SH1MINOXIDIL TABLET [AMERICAN HEALTH PACKAGING]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMINOXIDIL TABLET [AMERICAN HEALTH PACKAGING]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMINOXIDIL TABLET [AMERICAN HEALTH PACKAGING]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOXIDIL TABLET [AMERICAN HEALTH PACKAGING]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MINOXIDIL TABLET [AMERICAN HEALTH PACKAGING]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMINOXIDIL TABLET [AMERICAN HEALTH PACKAGING]3
MINOXIDILACTIVE INGREDIENT5965120SH1MINOXIDIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MINOXIDILACTIVE MOIETY5965120SH1MINOXIDIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMINOXIDIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMINOXIDIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MINOXIDIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOXIDIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMINOXIDIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-257MINOXIDIL TABLET [ENDO USA, INC.]9Current NDC, Legacy NDC, 2 package rows20241212_8f3800f0-b6da-4dfe-8c32-39bb5eb0262a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197986minoxidil 10 MG Oral TabletPSN934508f8-9252-4d48-ae91-0ce96454dc7b103
197986minoxidil 10 MG Oral TabletPSN6277d0dc-ac63-4393-a8ef-5350d9808876103
197986minoxidil 10 MG Oral TabletSCD6277d0dc-ac63-4393-a8ef-5350d9808876103
197986minoxidil 10 MG Oral TabletSCD934508f8-9252-4d48-ae91-0ce96454dc7b103
197986minoxidil 10 MG Oral TabletPSNb138c404-028c-4a73-a127-c96f2072e1f8102
197986minoxidil 10 MG Oral TabletSCDb138c404-028c-4a73-a127-c96f2072e1f8102
197986minoxidil 10 MG Oral TabletPSNe39469e6-d4f6-450f-872c-6f538e67c71a101
197986minoxidil 10 MG Oral TabletPSN665cba3d-5f26-468a-a047-188a413fbede101
197986minoxidil 10 MG Oral TabletSCDe39469e6-d4f6-450f-872c-6f538e67c71a101
197986minoxidil 10 MG Oral TabletSCD665cba3d-5f26-468a-a047-188a413fbede101
197986minoxidil 10 MG Oral TabletPSN0b4fc036-9497-442b-b629-c4b38693278911
197987minoxidil 2.5 MG Oral TabletPSN0b4fc036-9497-442b-b629-c4b38693278911
197986minoxidil 10 MG Oral TabletSCD0b4fc036-9497-442b-b629-c4b38693278911
197987minoxidil 2.5 MG Oral TabletSCD0b4fc036-9497-442b-b629-c4b38693278911
197986minoxidil 10 MG Oral TabletPSN8f3800f0-b6da-4dfe-8c32-39bb5eb0262a9
197987minoxidil 2.5 MG Oral TabletPSN8f3800f0-b6da-4dfe-8c32-39bb5eb0262a9
197986minoxidil 10 MG Oral TabletSCD8f3800f0-b6da-4dfe-8c32-39bb5eb0262a9
197987minoxidil 2.5 MG Oral TabletSCD8f3800f0-b6da-4dfe-8c32-39bb5eb0262a9
197986minoxidil 10 MG Oral TabletPSN1d134237-3e94-258e-e063-6294a90af5562
197986minoxidil 10 MG Oral TabletPSNf00f3370-0313-4ce0-be7d-80db4477d9ae2
197987minoxidil 2.5 MG Oral TabletPSN1d134237-3e94-258e-e063-6294a90af5562
197986minoxidil 10 MG Oral TabletSCD1d134237-3e94-258e-e063-6294a90af5562
197986minoxidil 10 MG Oral TabletSCDf00f3370-0313-4ce0-be7d-80db4477d9ae2
197987minoxidil 2.5 MG Oral TabletSCD1d134237-3e94-258e-e063-6294a90af5562
197986minoxidil 10 MG Oral TabletPSNa167ba5d-b01a-4142-910f-f3314159e8521
197986minoxidil 10 MG Oral TabletSCDa167ba5d-b01a-4142-910f-f3314159e8521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-257-0149884025701100 TABLET in 1 BOTTLE (49884-257-01) 100 tablet1988-11-140000-00-00NoNoCurrent
49884-257-0549884025705500 TABLET in 1 BOTTLE (49884-257-05) 500 tablet1988-11-140000-00-00NoNoCurrent