NDC 42571-312 Levocetirizine Dihydrochloride

Levocetirizine Dihydrochloride

NDC Product Code 42571-312

NDC Code: 42571-312

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 - WHITE TO OFF-WHITE)
Shape: OVAL (C48345)
Size(s):
8 MM
Imprint(s):
LI
Score: 2

Code Structure
  • 42571 - Micro Labs Limited
    • 42571-312 - Levocetirizine Dihydrochloride

NDC 42571-312-90

Package Description: 1 BOTTLE in 1 CARTON > 90 TABLET in 1 BOTTLE

NDC Product Information

Levocetirizine Dihydrochloride with NDC 42571-312 is a a human over the counter drug product labeled by Micro Labs Limited. The generic name of Levocetirizine Dihydrochloride is levocetirizine dihydrochloride. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Micro Labs Limited

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

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: Micro Labs Limited
Labeler Code: 42571
FDA Application Number: ANDA211551 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: 02-01-2019 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: 12-31-2019 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 nose sneezing itchy, watery eyes itching 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

  • If you have kidney disease if 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 drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

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

If Pregnant Or Breast-Feeding:

  • If breast-feeding: not recommended if 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 olderask a doctoradults and children 12-64 years of age take 1 tablet (5 mg) once daily in the eveningdo not take more than1 tablet (5 mg) in 24 hours½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptomschildren 6-11 years of agetake ½ tablet (2.5 mg) once daily in the eveningdo not take more than ½ tablet (2.5 mg) in 24 hourschildren under 6 years of agedo not useconsumers with kidney diseasedo not use

Storage

  • Store between 20° and 25°C (68° and 77°F) safety sealed: do not use if carton was opened or torn

Inactive Ingredients

Hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400 and titanium dioxide

* Please review the disclaimer below.

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