Cetirizine Hcl
Bionpharma Inc.
Human Otc Drug
NDC 69452-265Cetirizine Hcl is a human otc drug labeled by 'Bionpharma Inc.'. National Drug Code (NDC) number for Cetirizine Hcl is 69452-265. This drug is available in dosage form of Capsule. The names of the active, medicinal ingredients in Cetirizine Hcl drug includes Cetirizine Hydrochloride - 10 mg/1 . The currest status of Cetirizine Hcl drug is Active.
Drug Information:
| Drug NDC: | 69452-265 |
| 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 Hcl |
| 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 Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Bionpharma Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Capsule |
| 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: | NDA |
| 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: | 01 May, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 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: | NDA022429 |
| 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: | Bionpharma Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1014675
|
| 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. |
| 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 |
|---|
| 69452-265-15 | 1 BOTTLE, PLASTIC in 1 CARTON (69452-265-15) / 40 CAPSULE in 1 BOTTLE, PLASTIC | 01 May, 2019 | N/A | No |
| 69452-265-86 | 1 BOTTLE, PLASTIC in 1 CARTON (69452-265-86) / 25 CAPSULE in 1 BOTTLE, PLASTIC | 01 May, 2019 | N/A | No |
| 69452-265-88 | 1 BOTTLE, PLASTIC in 1 CARTON (69452-265-88) / 65 CAPSULE in 1 BOTTLE, PLASTIC | 01 May, 2019 | 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 hcl cetirizine hcl fd&c yellow no. 6 gelatin glycerin mannitol polyethylene glycol, unspecified water sodium hydroxide sorbitan sorbitol cetirizine hydrochloride cetirizine ce1
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. ask a doctor before use if you have liver or kidney disease. your doctor should determine if you need a different dose. ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. when using this product drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks 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. 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.
Do Not Use:
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. ask a doctor before use if you have liver or kidney disease. your doctor should determine if you need a different dose. ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. when using this product drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks 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. 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.
When Using:
When using this product drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery
Dosage and Administration:
Directions adults and children 6 years and over one 10 mg capsule once daily; do not take more than one 10 mg capsule 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:
Principal display panel - 65's carton compare to the active ingredient in zyrtec ® ndc 69452-265-88 a+health tm cetirizine hcl capsules, 10 mg antihistamine indoor & outdoor allergies 24 hour relief of: sneezing runny nose itchy, watery eyes itchy throat or nose 65 softgels** **liquid-filled capsule carton
Further Questions:
Questions or comments? call toll free 1-888-235-2466 (mon - fri 9am - 5pm est)