NDC 70518-1989 Cetirizine Hydrochloride

Cetirizine Hydrochloride

NDC Product Code 70518-1989

NDC Code: 70518-1989

Proprietary Name: Cetirizine Hydrochloride 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):
9 MM
Imprint(s):
10MG;APO
Score: 1

NDC Code Structure

  • 70518 - Remedyrepack Inc.
    • 70518-1989 - Cetirizine Hydrochloride

NDC 70518-1989-0

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

NDC 70518-1989-1

Package Description: 5 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

NDC Product Information

Cetirizine Hydrochloride with NDC 70518-1989 is a a human over the counter drug product labeled by Remedyrepack Inc.. The generic name of Cetirizine Hydrochloride is cetirizine hydrochloride. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Remedyrepack Inc.

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

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 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.

  • CETIRIZINE HYDROCHLORIDE 10 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.

  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • POLYDEXTROSE (UNII: VH2XOU12IE)
  • POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
  • 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: Remedyrepack Inc.
Labeler Code: 70518
FDA Application Number: ANDA078317 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: 03-27-2019 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.

Cetirizine Hydrochloride Product Label Images

Cetirizine Hydrochloride 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 HCl, USP 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

When Using This Product

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

Directions

Adults and children 6 years and overone 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptomsadults 65 years and overask a doctorchildren under 6 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor

Other Information

  • Store between 20° and 25°C (68° - 77°F)USP Dissolution Test 3

Inactive Ingredients

Lactose monohydrate, microcrystalline cellulose, starch (corn), magnesium stearate, hypromellose, polydextrose, polyethylene glycol and titanium dioxide.

* Please review the disclaimer below.

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