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  4. NDC Product Code: 59746-286 Cetirizine Hydrochloride

NDC 59746-286 Cetirizine Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 59746-286?
  5. Cetirizine Hydrochloride Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Get all the details for National Drug Code (NDC) 59746-286 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
59746-286
Proprietary Name:
Cetirizine Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Jubilant Cadista Pharmaceuticals Inc.
Labeler Code:
59746
Product Label ID:
3bbe5549-5678-a6ec-d854-2201cfe2bc76
FDA Application Number: [6]
ANDA091116
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
02-19-2015
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Navigator:

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)

Code Structure Chart

Product Details

What is NDC 59746-286?

The NDC code 59746-286 is assigned by the FDA to the product Cetirizine Hydrochloride which is product labeled by Jubilant Cadista Pharmaceuticals Inc.. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 59746-286-32 3 blister pack in 1 carton / 10 tablet, chewable in 1 blister pack, 59746-286-33 3 blister pack in 1 carton / 10 tablet, chewable in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Cetirizine Hydrochloride?

● 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 20° to 25° C (68° to 77° 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.

Which are Cetirizine Hydrochloride UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Cetirizine Hydrochloride Inactive Ingredients UNII Codes?

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. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Cetirizine Hydrochloride?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Patient Education

Cetirizine Injection


Cetirizine injection is used to treat acute urticaria in adults and children 6 months of age or older. Cetirizine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
[Learn More]


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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".