NDC 73057-387 Meclizine

Meclizine Hcl 25mg

NDC Product Code 73057-387

NDC Code: 73057-387

Proprietary Name: Meclizine 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.

Non-Proprietary Name: Meclizine Hcl 25mg 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.

NDC Code Structure

  • 73057 - Ulai Health Llc
    • 73057-387 - Meclizine

NDC 73057-387-08

Package Description: 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

NDC 73057-387-11

Package Description: 1000 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

NDC Product Information

Meclizine with NDC 73057-387 is a a human over the counter drug product labeled by Ulai Health Llc. The generic name of Meclizine is meclizine hcl 25mg. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Ulai Health Llc

Dosage Form: Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.

Product Type: Human Otc Drug 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.

Meclizine Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MECLIZINE HYDROCHLORIDE 25 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • DEXTROSE (UNII: IY9XDZ35W2)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Ulai Health Llc
Labeler Code: 73057
FDA Application Number: part336 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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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.

Start Marketing Date: 07-08-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Meclizine

Meclizine is pronounced as (mek' li zeen)

Why is meclizine medication prescribed?
Meclizine is used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness. It is most effective if taken before symptoms appear....
[Read More]

* Please review the disclaimer below.

Meclizine Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each Tablet)

Meclizine HCl 25mg

Purpose

Antiemetic

Uses

Prevents and treats nausea, vomiting or dizziness associated with motion sickness

Do Not Use

  • In children under 12 years of age unless directed by a doctor.Do not take this product, unless directed by a doctor, if you haveglaucomaa breathing problem such as emphysema or chronic bronchitistrouble urinating due to an enlarged prostate glandDo not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

When Using This Product

  • Do not exceed recommended dosagemay cause drowsinessalcohol, sedatives, and tranquilizers may increase drowsinessavoid alcoholic drinksuse causion when driving a motor vehicle or operating machinery

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • Dosage should be taken one hour before travel startsadults and children 12 years and overtake 1 or 2 tablets once daily or as directed by a doctor

Other Information

  • Store at 20o-25°C (68o-77°F)

Inactive Ingredients

Croscarmellose sodium, dextrose, FD&C Red#40, raspberry flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid

* Please review the disclaimer below.

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