Home NDC 51672-2151 Minoxidil Topical Solution, 5%
Product NDC 51672-2151
11-digit product format 516722151
Labeler code 51672
Product ID 51672-2151_4c37963d-9845-23d1-e063-6394a90aba45
Type HUMAN OTC DRUG
Nonproprietary name Minoxidil Solution
Dosage form SOLUTION
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA217998
Marketing category ANDA
Marketing start 2025-08-01
Substance MINOXIDIL
Active strength 50 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217998-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) MINOXIDIL 5% SOLUTION / TOPICAL 2025-06-30
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A217998-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2025-06-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217998-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2025-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217998-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2025-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217998-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2025-06-30 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217998-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2025-06-30 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Minoxidil Topical Solution, 5%
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MINOXIDIL 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5965120SH1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311724 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-2151-4 Minoxidil Topical Solution, 5% 60 mL in 1 BOTTLE SOLUTION 60 5 51672-2151-4 Minoxidil Topical Solution, 5% 1 in 1 CARTON SOLUTION 1 5 51672-2151-9 Minoxidil Topical Solution, 5% 3 in 1 CARTON SOLUTION 3 5 51672-2151-9 Minoxidil Topical Solution, 5% 60 mL in 1 BOTTLE SOLUTION 60 5
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51672-2151-4 51672215104 1 BOTTLE in 1 CARTON (51672-2151-4) / 60 mL in 1 BOTTLE 1 bottle 2025-08-01 No No Current 51672-2151-9 51672215109 3 BOTTLE in 1 CARTON (51672-2151-9) / 60 mL in 1 BOTTLE 3 bottle 2025-08-01 No No Current