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

Additional Listing Data#

Finished product
Yes
Brand name base
Minoxidil Topical Solution, 5%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui311724

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2151-4Minoxidil Topical Solution, 5%60 mL in 1 BOTTLESOLUTION605
51672-2151-4Minoxidil Topical Solution, 5%1 in 1 CARTONSOLUTION15
51672-2151-9Minoxidil Topical Solution, 5%3 in 1 CARTONSOLUTION35
51672-2151-9Minoxidil Topical Solution, 5%60 mL in 1 BOTTLESOLUTION605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2151-4ML - Milliliter51672-21517e4d51f6-77bd-4e93-99f9-8793b297ff7912025-11-13
51672-2151-9ML - Milliliter51672-2151d053cf11-667b-4d0a-a72e-0175978796b012025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSNacc5ad74-4558-4be9-aab4-94ad9ddad6b25
311724minoxidil 50 MG/ML Topical SolutionSCDacc5ad74-4558-4be9-aab4-94ad9ddad6b25
311724minoxidil 3 GM per 60 ML Topical SolutionSYacc5ad74-4558-4be9-aab4-94ad9ddad6b25
311724minoxidil 5 % Topical SolutionSYacc5ad74-4558-4be9-aab4-94ad9ddad6b25
311724minoxidil 5 GM per 100 ML Topical SolutionSYacc5ad74-4558-4be9-aab4-94ad9ddad6b25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51672-2151-4516722151041 BOTTLE in 1 CARTON (51672-2151-4) / 60 mL in 1 BOTTLE1 bottle2025-08-01NoNoCurrent
51672-2151-9516722151093 BOTTLE in 1 CARTON (51672-2151-9) / 60 mL in 1 BOTTLE3 bottle2025-08-01NoNoCurrent