ProBliva Mens Extra Strength Minoxidil

Product NDC
85464-595
11-digit product format
854640595
Labeler code
85464
Product ID
85464-595_33487e51-fb8b-0bea-e063-6294a90a728e
Type
HUMAN OTC DRUG
Nonproprietary name
MINOXIDIL
Dosage form
SOLUTION
Route
TOPICAL
Labeler
CAVTECH HOLDING LLC
Application
ANDA076239
Marketing category
ANDA
Marketing start
2025-04-04
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
ProBliva Mens Extra Strength Minoxidil
Listing expiration
2026-12-31

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
85464-595-00ProBliva Mens Extra Strength Minoxidil1 in 1 BOXSOLUTION11
85464-595-00ProBliva Mens Extra Strength Minoxidil60 mL in 1 BOTTLE, SPRAYSOLUTION601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85464-595PROBLIVA MENS EXTRA STRENGTH MINOXIDIL (MINOXIDIL) SOLUTION [CAVTECH HOLDING LLC]1Current NDC, 2 package rows20250425_84a2f311-e74c-4b50-bc55-dac604ca7694.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311724minoxidil 5 % Topical SolutionPSN84a2f311-e74c-4b50-bc55-dac604ca76941
311724minoxidil 50 MG/ML Topical SolutionSCD84a2f311-e74c-4b50-bc55-dac604ca76941
311724minoxidil 3 GM per 60 ML Topical SolutionSY84a2f311-e74c-4b50-bc55-dac604ca76941
311724minoxidil 5 % Topical SolutionSY84a2f311-e74c-4b50-bc55-dac604ca76941
311724minoxidil 5 GM per 100 ML Topical SolutionSY84a2f311-e74c-4b50-bc55-dac604ca76941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85464-595-00854640595001 BOTTLE, SPRAY in 1 BOX (85464-595-00) / 60 mL in 1 BOTTLE, SPRAY2025-04-04NoNoCurrent