Fexofenadine Hydrochloride
Chain Drug Consortium, Llc
Human Otc Drug
NDC 68016-995Fexofenadine Hydrochloride is a human otc drug labeled by 'Chain Drug Consortium, Llc'. National Drug Code (NDC) number for Fexofenadine Hydrochloride is 68016-995. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Fexofenadine Hydrochloride drug includes Fexofenadine Hydrochloride - 180 mg/1 . The currest status of Fexofenadine Hydrochloride drug is Active.
Drug Information:
| Drug NDC: | 68016-995 |
| 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: | Fexofenadine 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: | Fexofenadine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Chain Drug Consortium, 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: | FEXOFENADINE HYDROCHLORIDE - 180 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: | 01 Apr, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 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: | ANDA076502 |
| 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: | Chain Drug Consortium, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 997420
|
| 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. |
| UNII: | 2S068B75ZU
|
| 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 |
|---|
| 68016-995-03 | 1 BOTTLE in 1 CARTON (68016-995-03) / 30 TABLET in 1 BOTTLE | 01 Apr, 2014 | N/A | No |
| 68016-995-45 | 1 BOTTLE in 1 CARTON (68016-995-45) / 45 TABLET in 1 BOTTLE | 01 Apr, 2014 | 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:
Fexofenadine hydrochloride fexofenadine hydrochloride fexofenadine hydrochloride fexofenadine silicon dioxide croscarmellose sodium magnesium stearate mannitol powdered cellulose fd&c red no. 40 hypromellose 2910 (6 mpa.s) ferrosoferric oxide polyethylene glycol 400 titanium dioxide starch, corn 194;r containercarton
Indications and Usage:
Use(s) allergy temporarily relieves these symptoms due to hay fever or otherupper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat hives reduces hives and relieves itching due to hives (urticaria). this product will not prevent hives or an allergic skin reaction from occuring.
Warnings:
Warnings hives severe allergic warning: get emergency help immediately if you have hives along with any of the following symptom: trouble swallowing dizziness or loss of consciousness swelling of tongue swelling in or around mouth trouble speaking drooling wheezing or problems breathing these symptoms may be signs of anaphylactic shock. this condition canbe life threatening if not treated by a health professional immediately .symptoms of anaphylactic shock may occur when hives first appear or upto a few hours later. not a substitute for epinephrine. if your doctor has prescribed an epinephrineinjector for âanaphylaxisâ or severe allergy symptoms that could occur withyour hives, never use this product as a substitute for the epinephrine injector.if you have been prescribed an epinephrine injector, you should carry it withyou at all times. do not use allergy if you have ever had an allergic reaction to this product or any of its ingredients. hives to prevent hives from any know
Read more...n cause such as: foods insect stings medicines latex or rubber gloves because this product will 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 ask a doctor before use if you have allergy kidney disease. your doctorshould determine if you need a different dose. hives 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 when using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see directions) stop use and ask doctor if allergy an allergic reaction to this product occurs. seek medical help right away. hives 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 breast-feeding 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 hives severe allergic warning: get emergency help immediately if you have hives along with any of the following symptom: trouble swallowing dizziness or loss of consciousness swelling of tongue swelling in or around mouth trouble speaking drooling wheezing or problems breathing these symptoms may be signs of anaphylactic shock. this condition canbe life threatening if not treated by a health professional immediately .symptoms of anaphylactic shock may occur when hives first appear or upto a few hours later. not a substitute for epinephrine. if your doctor has prescribed an epinephrineinjector for âanaphylaxisâ or severe allergy symptoms that could occur withyour hives, never use this product as a substitute for the epinephrine injector.if you have been prescribed an epinephrine injector, you should carry it withyou at all times. do not use allergy if you have ever had an allergic reaction to this product or any of its ingredients. hives to prevent hives from any known cause such as: foods insect stings medicines latex or rubber gloves because this product will 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 ask a doctor before use if you have allergy kidney disease. your doctorshould determine if you need a different dose. hives 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 when using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see directions) stop use and ask doctor if allergy an allergic reaction to this product occurs. seek medical help right away. hives 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 breast-feeding 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 do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see directions)
Dosage and Administration:
Directions 180 mg adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor
Stop Use:
Stop use and ask doctor if allergy an allergic reaction to this product occurs. seek medical help right away. hives 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
Package Label Principal Display Panel:
Containercarton container carton label: 30 count
Further Questions:
Questions or comments? call toll-free 1-888-375-3784 manufactured by: dr. reddyâs laboratories limited bachupally - 500 090 india