NDC 0472-0066 Minoxidil Regular Strength For Men
Solution Topical

Product Information

What is NDC 0472-0066?

The NDC code 0472-0066 is assigned by the FDA to the product Minoxidil Regular Strength For Men which is a human over the counter drug product labeled by Actavis Pharma, Inc.. The product's dosage form is solution and is administered via topical form. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code	0472-0066
Proprietary Name What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.	Minoxidil Regular Strength For Men
Non-Proprietary Name What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.	Minoxidil
Product Type What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.	Human Otc Drug
Dosage Form	Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s) What are the Administration Route(s)? The translation of the route code submitted by the firm, indicating route of administration.	Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Product Labeler Information What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.	Actavis Pharma, Inc.
Labeler Code	0472
FDA Application Number What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.	ANDA074588
Marketing Category What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.	ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.	04-05-1996
Listing Expiration Date What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.	12-31-2022
Exclude Flag What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".	N
NDC Code Structure	0472 - Actavis Pharma, Inc. 0472-0066 - Minoxidil

What are the uses for Minoxidil Regular Strength For Men?

Minoxidil is used with other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Minoxidil works by relaxing blood vessels so blood can flow more easily.

Product Details

What are Minoxidil Regular Strength For Men Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

MINOXIDIL 2 g/100mL - A potent direct-acting peripheral vasodilator (VASODILATOR AGENTS) that reduces peripheral resistance and produces a fall in BLOOD PRESSURE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p371)

Minoxidil Regular Strength For Men Active Ingredients UNII Codes

MINOXIDIL (UNII: 5965120SH1)
MINOXIDIL (UNII: 5965120SH1) (Active Moiety)

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

RxCUI: 311723 - minoxidil 2 % Topical Solution
RxCUI: 311723 - minoxidil 20 MG/ML Topical Solution
RxCUI: 311723 - minoxidil 2 GM per 100 ML Topical Solution

Minoxidil Regular Strength For Men Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Patient Education

Minoxidil Oral

Minoxidil Oral is pronounced as (mi nox' i dill)

Why is minoxidil oral medication prescribed?
Minoxidil is used with other medications to treat high blood pressure. It is in a class of medications called vasodilators. It works by relaxing the blood vessels so that...
[Read More]

Minoxidil Topical

Minoxidil Topical is pronounced as (mi nox' i dill)

Why is minoxidil topical medication prescribed?
Minoxidil is used to stimulate hair growth and to slow balding. It is most effective for people under 40 years of age whose hair loss is recent. Minoxidil has no effect o...
[Read More]

* Please review the disclaimer below.

Minoxidil Regular Strength For Men Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Active Ingredient

Minoxidil, USP 2% w/v

Purpose

Hair regrowth treatment

Use

to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Warnings

For external use only
Flammable: Keep away from fire or flame

Do Not Use If

your degree of hair loss is different than that shown on the side of this carton, because this product may not work for you
you have no family history of hair loss
your hair loss is sudden and/or patchy
your hair loss is associated with childbirth
you do not know the reason for your hair loss
you are under 18 years of age. Do not use on babies and children.
your scalp is red, inflamed, infected, irritated, or painful
you use other medicines on the scalp

Ask A Doctor Before Use If You Have

heart disease

When Using This Product

do not apply on other parts of the body
avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
some people have experienced changes in hair color and/or texture
it takes time to regrow hair. You may need to use this product 2 times a day for at least 4 months before you see results.
the amount of hair regrowth is different for each person. This product will not work for everyone.

Stop Use And Ask A Doctor If

chest pain, rapid heartbeat, faintness, or dizziness occurs
sudden, unexplained weight gain occurs
your hands or feet swell
scalp irritation or redness occurs
unwanted facial hair growth occurs
you do not see hair regrowth in 4 months

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area
using more or more often will not improve results
continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

Other Information

see hair loss pictures on side of this carton
before use, read all information on carton and enclosed leaflet
keep the carton. It contains important information.
in clinical studies of mostly white men aged 18 to 49 years with moderate degrees of hair loss, the following response to minoxidil topical solution 2% for men was reported: 26% of men reported moderate to dense hair regrowth after using minoxidil topical solution 2% for men for 4 months (26% had moderate to dense regrowth; 33% had minimal regrowth). This compares with 11% of men reporting hair regrowth after using the placebo, the liquid without minoxidil in it, for 4 months (11% had moderate to dense regrowth; 31% had minimal regrowth).
store at controlled room temperature 20° to 25°C (68° to 77°F).

Inactive Ingredients

alcohol (60% v/v), propylene glycol, purified water

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

Principal Display Panel

Actavis

Compare to the active ingredient in Men’s Rogaine^®*

NDC 0472-0066-73

Regular Strength
FOR MEN
Minoxidil Topical
Solution, USP 2%

HAIR REGROWTH
TREATMENT

Reactivates Hair Follicles
to Stimulate Regrowth

Clinically Proven to
Help Regrow Hair

Unscented

FOR BEST RESULTS

APPLY DIRECTLY TO SCALP
TWICE DAILY

ONE MONTH SUPPLY
One 60 mL (2 fl oz) Bottle

Hair regrowth treatment for men

* Please review the disclaimer below.