NDC 58602-703 Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride
Tablet, Film Coated, Extended Release Oral

Product Information

NDC Product Code58602-703
Proprietary Name 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.
Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride
Non-Proprietary Name 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.
Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
Cetirizine Hydrochloride; Pseudoephedrine Hydrochloride
Product Type 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.
Human Otc Drug
NDC Directory StatusACTIVE PRODUCT and included in NDC Directory
Dosage FormTablet, Film Coated, Extended Release - 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; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
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.
Aurohealth Llc
Labeler Code58602
SPL SET ID:26f2c3c1-a2f2-474a-950a-8cfe07f289fa
FDA Application Number 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.
ANDA212409
Marketing Category 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.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
03-08-2023
Listing Expiration Date 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.
12-31-2024
Exclude Flag 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".
N
NDC Code Structure

Product Characteristics

Color(s)YELLOW (C48330 - PALE YELLOW TO YELLOW)
ShapeROUND (C48348)
Size(s)10 MM
Imprint(s)K15
Score1

Product Packages

NDC Code 58602-703-09

Package Description: 12 BLISTER PACK in 1 CARTON / 2 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

NDC Code 58602-703-53

Package Description: 12 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

NDC Code 58602-703-75

Package Description: 2 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

NDC Code 58602-703-76

Package Description: 4 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Product Details

What is NDC 58602-703?

The NDC code 58602-703 is assigned by the FDA to the product Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride which is a human over the counter drug product labeled by Aurohealth Llc. The product's dosage form is tablet, film coated, extended release and is administered via oral form. The product is distributed in 4 packages with assigned NDC codes 58602-703-09 12 blister pack in 1 carton / 2 tablet, film coated, extended release in 1 blister pack, 58602-703-53 12 blister pack in 1 carton / 1 tablet, film coated, extended release in 1 blister pack, 58602-703-75 2 blister pack in 1 carton / 6 tablet, film coated, extended release in 1 blister pack, 58602-703-76 4 blister pack in 1 carton / 6 tablet, film coated, extended release 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 And Pseudoephedrine Hydrochloride?

This product is used as AntihistamineNasal decongestant. Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose  sneezing itchy, watery eyesitching of the nose or throatnasal congestionreduces swelling of nasal passagestemporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose

What are Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Which are Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride UNII Codes?

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

Which are Cetirizine Hydrochloride And Pseudoephedrine 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:

Which are the Pharmacologic Classes for Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Product Label

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