Fexofenadine Hydrochloride
Sun Pharmaceutical Industries, Inc.
Human Otc Drug
NDC 62756-545Fexofenadine Hydrochloride is a human otc drug labeled by 'Sun Pharmaceutical Industries, Inc.'. National Drug Code (NDC) number for Fexofenadine Hydrochloride is 62756-545. This drug is available in dosage form of Tablet, Film Coated. 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: | 62756-545 |
| 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: | Sun Pharmaceutical Industries, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Film Coated |
| 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: | 30 Jun, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 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: | ANDA091567 |
| 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: | Sun Pharmaceutical Industries, Inc.
|
| 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. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0362756545151
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 62756-545-15 | 30 TABLET, FILM COATED in 1 BOTTLE (62756-545-15) | 30 Jun, 2022 | N/A | No |
| 62756-545-17 | 45 TABLET, FILM COATED in 1 BOTTLE (62756-545-17) | 30 Jun, 2022 | N/A | No |
| 62756-545-18 | 70 TABLET, FILM COATED in 1 BOTTLE (62756-545-18) | 30 Jun, 2022 | N/A | No |
| 62756-545-19 | 90 TABLET, FILM COATED in 1 BOTTLE (62756-545-19) | 30 Jun, 2022 | N/A | No |
| 62756-545-20 | 150 TABLET, FILM COATED in 1 BOTTLE (62756-545-20) | 30 Jun, 2022 | N/A | No |
| 62756-545-21 | 180 TABLET, FILM COATED in 1 BOTTLE (62756-545-21) | 30 Jun, 2022 | N/A | No |
| 62756-545-22 | 300 TABLET, FILM COATED in 1 BOTTLE (62756-545-22) | 30 Jun, 2022 | N/A | No |
| 62756-545-25 | 3 BLISTER PACK in 1 CARTON (62756-545-25) / 5 TABLET, FILM COATED in 1 BLISTER PACK (62756-545-31) | 30 Jun, 2022 | N/A | No |
| 62756-545-27 | 1 BLISTER PACK in 1 CARTON (62756-545-27) / 5 TABLET, FILM COATED in 1 BLISTER PACK (62756-545-31) | 30 Jun, 2022 | N/A | No |
| 62756-545-94 | 2 BLISTER PACK in 1 CARTON (62756-545-94) / 5 TABLET, FILM COATED in 1 BLISTER PACK (62756-545-31) | 30 Jun, 2022 | 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 microcrystalline cellulose starch, corn croscarmellose sodium magnesium stearate hypromellose 2910 (6 mpa.s) titanium dioxide polyethylene glycol 400 ferric oxide red ferric oxide yellow 545
Indications and Usage:
Uses reduces hives and relieves itching due to hives (urticaria). this product will not prevent hives or an 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 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 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 injector 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:
Warnings severe allergy warning: get emergency help immediately if you have hives along with any of the following symptoms: 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 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 injector 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.
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 for 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 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:
Principal display panel for 180 mg : label ndc 62756-545-15 fexofenadine hydrochloride tablets, usp 180 mg hives (24 hour) reduces hives and relieves itching due to hives antihistamine original prescription strength non-drowsy 30 tablets 180 mg each actual size bottle
Principal display panel for 180 mg : carton ndc 62756-545-15 fexofenadine hydrochloride tablets, usp 180 mg hives (24 hour) reduces hives and relieves itching due to hives antihistamine non-drowsy 30 tablets 180 mg each actual size bottle-carton
Principal display panel for 180 mg : blister pack ndc 62756-545-15 original prescription strength non-drowsy fexofenadine hydrochloride tablets, usp 180 mg hives (24 hour) reduces hives and relieves itching due to hives antihistamine 5 (1 x 5) tablets 180 mg each actual size do not use if individual blister unit is open or torn blister
Principal display panel for 180 mg : blister foil fexofenadine hydrochloride tablets, usp 24 hour 180 mg hives antihistamine mfg. by: sun pharmaceutical ind. ltd., india. foil