Minoxidil Topical Solution 2%

Product NDC
51672-2152
11-digit product format
516722152
Labeler code
51672
Product ID
51672-2152_4c3823f2-ce4b-afea-e063-6294a90a03c0
Type
HUMAN OTC DRUG
Nonproprietary name
Minoxidil Topical Solution 2%
Dosage form
SOLUTION
Route
TOPICAL
Labeler
SUN PHARMACEUTICAL INDUSTRIES, INC.
Application
ANDA218175
Marketing category
ANDA
Marketing start
2025-09-01
Substance
MINOXIDIL
Active strength
20 mg/mL
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 · 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
A218175-001MINOXIDIL (FOR WOMEN)MINOXIDIL2%SOLUTION / TOPICAL2024-11-26

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A218175-001MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL2024-11-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218175-001MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL2024-11-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218175-001MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL2024-11-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A218175-001MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL2024-11-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218175-001MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL2024-11-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218175-001MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL2024-11-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218175-001MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL2024-11-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218175-001MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL2024-11-262680178bc6a6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218175-001MINOXIDIL (FOR WOMEN)2%SOLUTION / TOPICAL2024-11-26a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Minoxidil Topical Solution 2%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL20 mg/mL

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
311723Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
15d7cdd7-6d37-477c-bce7-a459ea960a53Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2152-4Minoxidil Topical Solution 2%60 mL in 1 BOTTLESOLUTION604
51672-2152-4Minoxidil Topical Solution 2%1 in 1 CARTONSOLUTION14
51672-2152-9Minoxidil Topical Solution 2%60 mL in 1 BOTTLESOLUTION604
51672-2152-9Minoxidil Topical Solution 2%3 in 1 CARTONSOLUTION34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2152-4ML - Milliliter51672-21520275bce8-d20c-4206-85e4-6ecffb71b58112026-03-17
51672-2152-9ML - Milliliter51672-215256db65fc-1ec6-426b-8527-9910b596571b12026-03-17

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Minoxidil Topical Solution 2%MINOXIDIL TOPICAL SOLUTION 2%SUN PHARMACEUTICAL INDUSTRIES, INC.15d7cdd7-6d37-477c-bce7-a459ea960a532026-03-04WarningsExact identifier
application applno (ANDA): 218175
application number: ANDA218175
ndc (product): 51672-2152

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311723minoxidil 2 % Topical SolutionPSN15d7cdd7-6d37-477c-bce7-a459ea960a534
311723minoxidil 20 MG/ML Topical SolutionSCD15d7cdd7-6d37-477c-bce7-a459ea960a534
311723minoxidil 2 % Topical SolutionSY15d7cdd7-6d37-477c-bce7-a459ea960a534
311723minoxidil 2 GM per 100 ML Topical SolutionSY15d7cdd7-6d37-477c-bce7-a459ea960a534

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51672-2152-4516722152041 BOTTLE in 1 CARTON (51672-2152-4) / 60 mL in 1 BOTTLE1 bottle2025-09-01NoNoCurrent
51672-2152-9516722152093 BOTTLE in 1 CARTON (51672-2152-9) / 60 mL in 1 BOTTLE3 bottle2025-09-01NoNoCurrent