GROWELL Womens Hair Regrowth Treatment 2 Minoxidil

Product NDC
84329-466
11-digit product format
843290466
Labeler code
84329
Product ID
84329-466_189129cb-e2fa-59f0-e063-6394a90a33b2
Type
HUMAN OTC DRUG
Nonproprietary name
MINOXIDIL
Dosage form
LIQUID
Route
TOPICAL
Labeler
APIRA SCIENCE, INC.
Application
ANDA078176
Marketing category
ANDA
Marketing start
2024-03-04
Substance
MINOXIDIL
Active strength
20 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
GROWELL Womens Hair Regrowth Treatment 2 Minoxidil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOXIDIL20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5965120SH1
Rxcui311723

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84329-466-00GROWELL Womens Hair Regrowth Treatment 2 Minoxidil1 in 1 BOXLIQUID11
84329-466-00GROWELL Womens Hair Regrowth Treatment 2 Minoxidil60 mL in 1 BOTTLE, DROPPERLIQUID601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84329-466GROWELL WOMENS HAIR REGROWTH TREATMENT 2 MINOXIDIL (MINOXIDIL) LIQUID [APIRA SCIENCE, INC.]1Current NDC, 2 package rows20240517_8b81a5e5-315e-4b7d-8ffd-623382294d8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311723minoxidil 2 % Topical SolutionPSN8b81a5e5-315e-4b7d-8ffd-623382294d8a1
311723minoxidil 20 MG/ML Topical SolutionSCD8b81a5e5-315e-4b7d-8ffd-623382294d8a1
311723minoxidil 2 % Topical SolutionSY8b81a5e5-315e-4b7d-8ffd-623382294d8a1
311723minoxidil 2 GM per 100 ML Topical SolutionSY8b81a5e5-315e-4b7d-8ffd-623382294d8a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84329-466-00843290466001 BOTTLE, DROPPER in 1 BOX (84329-466-00) / 60 mL in 1 BOTTLE, DROPPER2024-03-04NoNoHistorical