Fexofenadine Hcl
Preferred Pharmaceuticals, Inc.
Human Otc Drug
NDC 68788-7449Fexofenadine Hcl is a human otc drug labeled by 'Preferred Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Fexofenadine Hcl is 68788-7449. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Fexofenadine Hcl drug includes Fexofenadine Hydrochloride - 180 mg/1 . The currest status of Fexofenadine Hcl drug is Active.
Drug Information:
| Drug NDC: | 68788-7449 |
| 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 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: | Fexofenadine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Preferred Pharmaceuticals, Inc. |
| 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: | 19 Aug, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 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: | ANDA204097 |
| 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: | Preferred Pharmaceuticals, 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. |
| 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 |
|---|
| 68788-7449-1 | 100 TABLET in 1 BOTTLE (68788-7449-1) | 27 Dec, 2019 | N/A | No |
| 68788-7449-3 | 30 TABLET in 1 BOTTLE (68788-7449-3) | 27 Dec, 2019 | N/A | No |
| 68788-7449-6 | 60 TABLET in 1 BOTTLE (68788-7449-6) | 27 Dec, 2019 | N/A | No |
| 68788-7449-9 | 90 TABLET in 1 BOTTLE (68788-7449-9) | 27 Dec, 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:
Fexofenadine hcl fexofenadine hcl fexofenadine hydrochloride fexofenadine silicon dioxide hypromellose 2910 (6 mpa.s) light mineral oil magnesium stearate microcrystalline cellulose polysorbate 80 starch, corn ferric oxide red ferric oxide yellow sodium starch glycolate type a potato talc titanium dioxide polyethylene glycol 6000 j;44
Indications and Usage:
Use(s) 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:
Warnings
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 60 mg adults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets 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 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 a doctor if an allergic reaction to this product occurs. seek medical help right away. if pregnant or breast-feeding, ask a health professional before use.
Package Label Principal Display Panel:
Principal display panel fexofenadine hydrochloride tablets, usp 180 mg \ ndc 68788-7449 repackaged by preferred pharmaceuticals, inc. fexofenadine hydrochloride tablets, usp 180 mg fexofenadine hcl tablets 180mg
Further Questions:
Questions or comments call toll-free weekdays 9 am to 5 pm est at 1-888-588-1418