NDC 59746-286 Cetirizine Hydrochloride

Cetirizine Hydrochloride

NDC Product Code 59746-286

NDC CODE: 59746-286

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):
ORANGE (C48331)
Shape: ROUND (C48348)
Size(s):
8 MM
11 MM
Imprint(s):
C285
C286
Score: 1
Flavor(s):
ORANGE (C73406)

NDC Code Structure

NDC 59746-286-32

Package Description: 3 BLISTER PACK in 1 CARTON > 10 TABLET, CHEWABLE in 1 BLISTER PACK

Price per Unit: $1.68719 per EA

NDC 59746-286-33

Package Description: 3 BLISTER PACK in 1 CARTON > 10 TABLET, CHEWABLE in 1 BLISTER PACK

NDC Product Information

Cetirizine Hydrochloride with NDC 59746-286 is a a human over the counter drug product labeled by Jubilant Cadista Pharmaceuticals Inc.. The generic name of Cetirizine Hydrochloride is cetirizine hydrochloride. The product's dosage form is tablet, chewable and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1014643 and 1014674.

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.

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.


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.

  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • ASPARTAME (UNII: Z0H242BBR1)
  • BETADEX (UNII: JV039JZZ3A)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
  • ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • FUMARIC ACID (UNII: 88XHZ13131)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MANNITOL (UNII: 3OWL53L36A)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • TALC (UNII: 7SEV7J4R1U)
  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • ASPARTAME (UNII: Z0H242BBR1)
  • BETADEX (UNII: JV039JZZ3A)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
  • ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • FUMARIC ACID (UNII: 88XHZ13131)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MANNITOL (UNII: 3OWL53L36A)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • TALC (UNII: 7SEV7J4R1U)

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.
  • 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: Jubilant Cadista Pharmaceuticals Inc.
Labeler Code: 59746
FDA Application Number: ANDA091116 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: 02-19-2015 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: 12-31-2021 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.

Information for Patients

Cetirizine

Cetirizine is pronounced as (se ti' ra zeen)

Why is cetirizine medication prescribed?
Cetirizine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and allergy to other substances (such as dus...
[Read More]

* Please review the disclaimer below.

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 Chewable Tablet )

Cetirizine Hydrochloride 5 mg Cetirizine Hydrochloride 10 mg

Purpose

Antihistamine

Uses:

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat

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

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 at (1-800-222-1222).

Directions:

  • ● may be taken with and without waterFor Cetirizine hydrochloride chewable tablets 5 mg adults and children 6 years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.adults 65 years and over1 tablet once a day; do not take more than 1 tablet in 24 hours.children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor For Cetirizine hydrochloride chewable tablets 10 mg adults and children 6 years and over one 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 symptoms. adults 65 years and overask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information:store between 20º to 25º C (68º to 77º F) Phenylketonurics: Contains 1.68 mg Phenylalanine (a component of Aspartame) per 5 mgPhenylketonurics: Contains 3.36 mg Phenylalanine (a component of Aspartame) per 10 mgdo not use if carton is opened or if blister unit is broken.see bottom panel for lot number and expiration date.

Inactive Ingredients:

Acesulfame potassium, artificial and natural flavors, aspartame, betadex, colloidal silicon dioxide, croscarmellose sodium, dl-alpha-tocopherol, ethyl cellulose, FD&C yellow # 6 aluminum lake, fumaric acid, hypromellose, magnesium stearate, mannitol, maltodextrin, microcrystalline cellulose and talc.

Questions? Call 1-800-313-4623

Manufactured by:Jubilant Generics Ltd.Roorkee-247661, IndiaMarketed by:Jubilant Cadista Pharmaceuticals Inc.Salisbury, MD 21801, USARevised : November / 2014

* Please review the disclaimer below.