Elevate Hair Regrowth Treatment 5

Product NDC
84561-524
11-digit product format
845610524
Labeler code
84561
Product ID
84561-524_25d0836a-9506-d6a2-e063-6394a90aaa8f
Type
HUMAN OTC DRUG
Nonproprietary name
MINOXIDIL
Dosage form
SOLUTION
Route
TOPICAL
Labeler
VAPOR PRO SHOPPE, LLC
Application
ANDA076239
Marketing category
ANDA
Marketing start
2024-07-16
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui1537948

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
84561-524-00Elevate Hair Regrowth Treatment 560 mL in 1 BOTTLE, SPRAYSOLUTION602
84561-524-00Elevate Hair Regrowth Treatment 51 in 1 BOXSOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84561-524ELEVATE HAIR REGROWTH TREATMENT 5 (MINOXIDIL) SOLUTION [VAPOR PRO SHOPPE, LLC]2Current NDC, 2 package rows20241102_0d5e4258-a58d-4378-9be8-631114588cdb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1537948minoxidil 5 % Topical SprayPSN0d5e4258-a58d-4378-9be8-631114588cdb2
1537948minoxidil 50 MG/ML Topical SpraySCD0d5e4258-a58d-4378-9be8-631114588cdb2
1537948minoxidil 5 % Topical SpraySY0d5e4258-a58d-4378-9be8-631114588cdb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84561-524-00845610524001 BOTTLE, SPRAY in 1 BOX (84561-524-00) / 60 mL in 1 BOTTLE, SPRAY2024-07-16NoNoHistorical