Elevate Hair Regrowth Treatment 5 Minoxidil Solution

Product NDC
84561-514
11-digit product format
845610514
Labeler code
84561
Product ID
84561-514_1dd4240e-bb41-0d06-e063-6394a90a36d5
Type
HUMAN OTC DRUG
Nonproprietary name
MINOXIDIL
Dosage form
SOLUTION
Route
TOPICAL
Labeler
VAPOR PRO SHOPPE, LLC
Application
ANDA076239
Marketing category
ANDA
Marketing start
2024-07-08
Substance
MINOXIDIL
Active strength
50 mg/mL
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
Elevate Hair Regrowth Treatment 5 Minoxidil Solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui311724

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84561-514-00Elevate Hair Regrowth Treatment 5 Minoxidil Solution1 in 1 BOXSOLUTION11
84561-514-00Elevate Hair Regrowth Treatment 5 Minoxidil Solution60 mL in 1 BOTTLE, DROPPERSOLUTION601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84561-514ELEVATE HAIR REGROWTH TREATMENT 5 MINOXIDIL SOLUTION (MINOXIDIL) SOLUTION [VAPOR PRO SHOPPE, LLC]1Current NDC, 2 package rows20240723_12737299-1052-4c93-afab-20016b9d9001.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSN12737299-1052-4c93-afab-20016b9d90011
311724minoxidil 50 MG/ML Topical SolutionSCD12737299-1052-4c93-afab-20016b9d90011
311724minoxidil 3 GM per 60 ML Topical SolutionSY12737299-1052-4c93-afab-20016b9d90011
311724minoxidil 5 % Topical SolutionSY12737299-1052-4c93-afab-20016b9d90011
311724minoxidil 5 GM per 100 ML Topical SolutionSY12737299-1052-4c93-afab-20016b9d90011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84561-514-00845610514001 BOTTLE, DROPPER in 1 BOX (84561-514-00) / 60 mL in 1 BOTTLE, DROPPER2024-07-08NoNoCurrent