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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071839-001MINOXIDILMINOXIDIL10MGTABLET / ORALAB1988-11-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A071839-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-143f01610625f2…
2019-09-15 20:21 UTC2019-09A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071839-001MINOXIDIL10MGTABLET / ORALAB1988-11-14e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A071839-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071839-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071839-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071839-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071839-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071839-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071839-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071839-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071839-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071839-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071839-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071839-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071839-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071839-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071839-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071839-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071839-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071839-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071839-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071839-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071839-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071839-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A071839-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071839-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071839-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071839-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A071839-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A071839-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071839-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071839-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071839-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071839-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071839-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071839-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071839-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A071839-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A071839-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071839-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071839-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071839-001AB1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL10 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
8f3800f0-b6da-4dfe-8c32-39bb5eb0262aAvailable on FDA.report

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

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MinoxidilMINOXIDILBryant Ranch Prepack665cba3d-5f26-468a-a047-188a413fbede2026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071839
application number: ANDA071839
MinoxidilMINOXIDILBryant Ranch Prepackb138c404-028c-4a73-a127-c96f2072e1f82026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071839
application number: ANDA071839
MinoxidilMINOXIDILBryant Ranch Prepacke39469e6-d4f6-450f-872c-6f538e67c71a2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071839
application number: ANDA071839
MinoxidilMINOXIDILBryant Ranch Prepack934508f8-9252-4d48-ae91-0ce96454dc7b2026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071839
application number: ANDA071839
MinoxidilMINOXIDILGolden State Medical Supply, Inc.1d134237-3e94-258e-e063-6294a90af5562026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071839
application number: ANDA071839
MinoxidilMINOXIDILPar Health USA, LLC8f3800f0-b6da-4dfe-8c32-39bb5eb0262a2026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071839
application number: ANDA071839
ndc (product): 49884-257
MinoxidilMINOXIDILAmerican Health Packaging0b4fc036-9497-442b-b629-c4b3869327892025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071839
application number: ANDA071839
MinoxidilMINOXIDILA-S Medication Solutionsf00f3370-0313-4ce0-be7d-80db4477d9ae2025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071839
application number: ANDA071839
MinoxidilMINOXIDILBryant Ranch Prepack6277d0dc-ac63-4393-a8ef-5350d98088762024-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071839
application number: ANDA071839

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