Cetirizine Hydrochloride
Cetirizine
Amneal Pharmaceuticals Llc
Human Otc Drug
NDC 65162-003Cetirizine Hydrochloride also known as Cetirizine is a human otc drug labeled by 'Amneal Pharmaceuticals Llc'. National Drug Code (NDC) number for Cetirizine Hydrochloride is 65162-003. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Cetirizine Hydrochloride drug includes Cetirizine Hydrochloride - 5 mg/5mL . The currest status of Cetirizine Hydrochloride drug is Active.
Drug Information:
| Drug NDC: | 65162-003 |
| 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 |
| 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 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Amneal Pharmaceuticals Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| 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 - 5 mg/5mL
|
| 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: | 07 Oct, 2009 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 05 May, 2026 |
| 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: | ANDA090765 |
| 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, 2023 |
| 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: | Amneal Pharmaceuticals LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1014673
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0365162003864
|
| UPC stands for Universal Product Code. |
| UNII: | 64O047KTOA
|
| 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 |
|---|
| 65162-003-86 | 1 BOTTLE in 1 CARTON (65162-003-86) / 118 mL in 1 BOTTLE | 07 Oct, 2009 | 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 cetirizine cetirizine hydrochloride cetirizine acetic acid glycerin methylparaben propylene glycol propylparaben sodium acetate sucrose water clear to pale yellow
Indications and Usage:
Uses relieves itching due to hives (urticaria). this product will not prevent hives or a allergic skin reaction from occurring.
Warnings:
Warnings severe allergy warning: get emergency help immediately if you have hives along with any of the following symptoms: trouble swallowing swelling of tongue trouble speaking wheezing or problems breathing dizziness or loss of consciousness swelling in or around the mouth drooling the symptoms may be signs of anaphylactic shock. this condition can be life threatening if not treated by a health professional immediately . symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later. not a substitute for epinephrine. if your doctor has prescribed an epinephrine injection for âanaphylaxisâ or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. if you have been prescribed an epinephrine injector, you should carry it with you at all times. do not use to prevent hives from any known cause such as: foods insect stings medicines latex or rubber gloves because this product will
Read more... not stop hives from occurring. avoiding the cause of your hives is the only way to prevent them. hives can sometimes be serious. if you do not know the cause of your hives, see your doctor for a medical exam. your doctor may be able to help you find a cause if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. ask a doctor before use if you have liver or kidney disease. your doctor should determine if you need a different dose. hives that are an unusual color, look bruised or blistered hives that do not itch ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. 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 stop use and ask a doctor if an allergic reaction to this product occurs. seek medical help right away. symptoms do not improve after 3 days of treatment the hives have lasted more than 6 weeks if pregnant or breastfeeding: if breast-feeding: not recommended if pregnant: ask a health professional before use
Dosage and Administration:
Directions use only with enclosed dosing cup find right dose on chart below ml = milliliter adults and children 6 years and over 1 teaspoonful (5 ml) or 2 teaspoonfuls (10 ml) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 ml) in 24 hours. adults 56 years and over 1 teaspoonful (5 ml) once daily; do not take more than 1 teaspoonful (5 ml) in 24 hours. 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) tamper evident: do not use if neckband imprinted âsealed for your protectionâ is broken or misssing.
Package Label Principal Display Panel:
Package label.principal display panel 1 mg/ml label 1 mg/ml carton