growell mens hair regrowth treatment 5 minoxidil

Generic: minoxidil

Labeler: apira science, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name growell mens hair regrowth treatment 5 minoxidil
Generic Name minoxidil
Labeler apira science, inc.
Dosage Form LIQUID
Routes
TOPICAL
Active Ingredients

minoxidil 50 mg/mL

Manufacturer
APIRA SCIENCE, INC.

Identifiers & Regulatory

Product NDC 84329-465
Product ID 84329-465_18911e7d-a92e-7b65-e063-6294a90a9429
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076239
Listing Expiration 2026-12-31
Marketing Start 2024-03-04

Pharmacologic Class

Established (EPC)
arteriolar vasodilator [epc]
Physiologic Effect
arteriolar vasodilation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84329465
Hyphenated Format 84329-465

Supplemental Identifiers

RxCUI
311724
UNII
5965120SH1
NUI
N0000175379 N0000175564

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name growell mens hair regrowth treatment 5 minoxidil (source: ndc)
Generic Name minoxidil (source: ndc)
Application Number ANDA076239 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 BOX (84329-465-00) / 60 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

84329-465-00 1 BOTTLE, DROPPER in 1 BOX (84329-465-00) / 60 mL in 1 BOTTLE, DROPPER

Ingredients (1)

minoxidil (50 mg/mL)

Linked Drug Pages (1)

GROWELL Mens Hair Regrowth Treatment 5 Minoxidil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "18911e7d-a92e-7b65-e063-6294a90a9429", "openfda": {"nui": ["N0000175379", "N0000175564"], "unii": ["5965120SH1"], "rxcui": ["311724"], "spl_set_id": ["8cd4a3a9-94ba-48c7-8516-b50504c2c440"], "pharm_class_pe": ["Arteriolar Vasodilation [PE]"], "pharm_class_epc": ["Arteriolar Vasodilator [EPC]"], "manufacturer_name": ["APIRA SCIENCE, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 BOX (84329-465-00)  / 60 mL in 1 BOTTLE, DROPPER", "package_ndc": "84329-465-00", "marketing_start_date": "20240304"}], "brand_name": "GROWELL Mens Hair Regrowth Treatment 5 Minoxidil", "product_id": "84329-465_18911e7d-a92e-7b65-e063-6294a90a9429", "dosage_form": "LIQUID", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "84329-465", "generic_name": "MINOXIDIL", "labeler_name": "APIRA SCIENCE, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "GROWELL Mens Hair Regrowth Treatment 5 Minoxidil", "active_ingredients": [{"name": "MINOXIDIL", "strength": "50 mg/mL"}], "application_number": "ANDA076239", "marketing_category": "ANDA", "marketing_start_date": "20240304", "listing_expiration_date": "20261231"}