NDC 73581-202 Cetirizine Hydrochloride 10 Mg

Cetirizine Hydrochloride

NDC Product Code 73581-202

NDC CODE: 73581-202

Proprietary Name: Cetirizine Hydrochloride 10 Mg 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: Cetirizine Hydrochloride 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: RECTANGLE (C48347)
Size(s):
10 MM
Imprint(s):
G4
Score: 2

NDC Code Structure

NDC 73581-202-01

Package Description: 100 TABLET in 1 BOTTLE

NDC 73581-202-05

Package Description: 500 TABLET in 1 BOTTLE

NDC Product Information

Cetirizine Hydrochloride 10 Mg with NDC 73581-202 is a a human over the counter drug product labeled by Yyba Corp. The generic name of Cetirizine Hydrochloride 10 Mg is cetirizine hydrochloride. The product's dosage form is tablet and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1014678.

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.

Cetirizine Hydrochloride 10 Mg 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.


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)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: Yyba Corp
Labeler Code: 73581
FDA Application Number: ANDA209274 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: 06-16-2021 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: 12-31-2022 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 - NO 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".

* Please review the disclaimer below.

Cetirizine Hydrochloride 10 Mg Product Label Images

Cetirizine Hydrochloride 10 Mg 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)

Cetirizine Hydrochloride 10 mg

Purpose

Antihistamine

Uses

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

Warnings

  • Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyine.Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.When using this product:drowsiness may occuravoid alcoholic drinksalcohol, sedatives and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machineryStop use and ask a doctor if an 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

Otc - Keep Out Of Reach Of Children

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 and children 6 years and overtake one 10 mg tablet oncedaily; do not take more than one 10mg tablet in 24 hours. A 5mg product may be appropriate for less severe symptoms.adults 65 years and older ask a doctorchildren under 6 years of age ask a doctorconsumers with liver or kidney diseaseask a doctor

Other Information

  • Store between 20° and 25°C (68° and 77°F)

Inactive Ingredients

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

Questions?

Call toll-free 1-866-933-6337

* Please review the disclaimer below.