NDC 37808-126 Levocetirizine Dihydrochloride

Levocetirizine Dihydrochloride

NDC Product Code 37808-126

NDC Code: 37808-126

Proprietary Name: Levocetirizine Dihydrochloride 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: Levocetirizine Dihydrochloride 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.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: OVAL (C48345)
Size(s):
9 MM
Imprint(s):
L
Score: 2

NDC Code Structure

  • 37808 - Heb
    • 37808-126 - Levocetirizine Dihydrochloride

NDC 37808-126-10

Package Description: 2 BLISTER PACK in 1 BLISTER PACK > 5 TABLET, COATED in 1 BLISTER PACK

NDC 37808-126-35

Package Description: 1 BOTTLE in 1 BOTTLE > 35 TABLET, COATED in 1 BOTTLE

NDC Product Information

Levocetirizine Dihydrochloride with NDC 37808-126 is a a human over the counter drug product labeled by Heb. The generic name of Levocetirizine Dihydrochloride is levocetirizine dihydrochloride. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Heb

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

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.

Levocetirizine Dihydrochloride 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.

  • LEVOCETIRIZINE DIHYDROCHLORIDE 5 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.

  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

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: Heb
Labeler Code: 37808
FDA Application Number: ANDA210375 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: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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: 06-15-2019 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.

Levocetirizine Dihydrochloride Product Label Images

Levocetirizine Dihydrochloride 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)

Levocetirizine dihydrochloride USP, 5 mg

Purpose

Antihistamine

Uses

  • Temporarily relieves these symptoms due to hay fever or other respiratory allergies:runny nosesneezingitchy, watery eyesitching of the nose or throat

Do Not Use

  • If you have kidney diseaseif you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine

Ask A Doctor Before Use If You Have

  • Ever had trouble urinating or emptying your bladder

When Using This Product

  • Drowsiness may occur avoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machinery

Stop Use And Ask Doctor If

  • You have trouble urinating or emptying your bladderan allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breast-Feeding:

  • If breast-feeding: not recommendedif pregnant: 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

  • Adults 65 years of age and older ask a doctor adults and children 12-64 years of age take 1 tablet (5 mg) once daily in the eveningdo not take more than 1 tablet (5 mg) in 24 hours 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms children 6-11 years of age take 1/2 tablet (2.5 mg) once daily in the eveningdo not take more than 1/2 tablet (2.5 mg) in 24 hours children under 6 years of age do not use consumers with kidney disease do not use

Other Information

  • Store between 20° and 25°C (68° and 77°F)safety sealed: Bottle: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing Blister: Do not use if seal is broken or if individualblister unit is open or torn

Inactive Ingredients

Colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

* Please review the disclaimer below.

Previous Code
37808-124
Next Code
37808-130