Cetirizine Hydrochloride (allergy)
Cetirizine Hydrochloride
Aurohealth Llc
Human Otc Drug
NDC 58602-861Cetirizine Hydrochloride (allergy) also known as Cetirizine Hydrochloride is a human otc drug labeled by 'Aurohealth Llc'. National Drug Code (NDC) number for Cetirizine Hydrochloride (allergy) is 58602-861. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Cetirizine Hydrochloride (allergy) drug includes Cetirizine Hydrochloride - 10 mg/1 . The currest status of Cetirizine Hydrochloride (allergy) drug is Active.
Drug Information:
| Drug NDC: | 58602-861 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Cetirizine Hydrochloride (allergy) |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Cetirizine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Aurohealth Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CETIRIZINE HYDROCHLORIDE - 10 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 10 Feb, 2023 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA090760 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | |
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 58602-861-21 | 1 BOTTLE in 1 CARTON (58602-861-21) / 100 TABLET in 1 BOTTLE | 10 Feb, 2023 | N/A | No |
| 58602-861-29 | 1 BOTTLE in 1 CARTON (58602-861-29) / 150 TABLET in 1 BOTTLE | 10 Feb, 2023 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose antihistamine
Product Elements:
Cetirizine hydrochloride (allergy) cetirizine hydrochloride cetirizine hydrochloride cetirizine silicon dioxide croscarmellose sodium hypromellose 2910 (5 mpa.s) lactose monohydrate magnesium stearate microcrystalline cellulose polyethylene glycol 400 titanium dioxide white to off-white x;36
Indications and Usage:
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
Warnings:
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 hydroxyzine.
When Using:
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
Dosage and Administration:
Directions 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 over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor
Stop Use:
Stop use and ask a doctor if an allergic reaction to this product occurs. seek medical help right away.
Package Label Principal Display Panel:
Package label-principal display panel - 10 mg (100's tablet bottle) healthy living ⢠allergy relief cetirizine hydrochloride tablets usp 10 mg antihistamine original prescription strength 100 tablets 10 mg each package label-principal display panel - 10 mg (30's tablet bottle)
Package label-principal display panel - 10 mg (100's container carton label) healthy living ⢠allergy relief cetirizine hydrochloride tablets usp 10 mg antihistamine original prescription strength *compare to the active ingredient of zyrtec ® indoor & outdoor allergies 24 hour relief of: sneezing runny nose itchy, watery eyes itchy throat or nose 100 tablets 10 mg each package label-principal display panel - 10 mg (container carton label)
Further Questions:
Questions? call 1-855-274-4122 distributed by: aurohealth llc 279 princeton-hightstown road east windsor, nj 08520 made in india code: ts/drugs/19/1993