NDC 50268-317 Fexofenadine Hydrochloride

Fexofenadine Hydrochloride

NDC Product Code 50268-317

NDC Code: 50268-317

Proprietary Name: Fexofenadine Hydrochloride What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Fexofenadine Hydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
ORANGE (C48331 - PEACH)
Shape: CAPSULE (C48336)
Size(s):
12 MM
Imprint(s):
E;42
Score: 1

NDC Code Structure

  • 50268 - Avpak

NDC 50268-317-13

Package Description: 30 BLISTER PACK in 1 BOX > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-317-11)

NDC Product Information

Fexofenadine Hydrochloride with NDC 50268-317 is a a human over the counter drug product labeled by Avpak. The generic name of Fexofenadine Hydrochloride is fexofenadine hydrochloride. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Avpak

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Fexofenadine Hydrochloride Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • FEXOFENADINE HYDROCHLORIDE 60 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Avpak
Labeler Code: 50268
FDA Application Number: ANDA202039 What is the FDA Application Number?
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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 05-28-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Fexofenadine Hydrochloride Product Label Images

Fexofenadine Hydrochloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient(In Each Tablet)

Fexofenadine HCl USP, 60 mg

Purpose

Antihistamine

Uses

  • Temporarily relieves these symptoms due to hay fever or other upper resporatory allergies:runny nose sneezing itchy, watery eyes itching of the nose or throat

Do Not Use

If you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If You Have

Kidney disease. Your doctor should determine if you need a different dose.

When Using This Product

  • Do not take more than directeddo not take at the same time as aluminium or magnesium antacidsdo not take with fruit juices (see directions)

Stop Use And Ask 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.

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and overtake one 180 mg tablet with water once a day;


do not take more than 1 tablet in 24 hours


children under 12 years of agedo not useadults 65 years of age and olderask a doctorconsumers with kidney diseaseask a doctoradults and children 12 years of age and overtake one 60 mg tablet with water every 12 hours;


do not take more than 2 tablet in 24 hours


children under 12 years of agedo not useadults 65 years of age and olderask a doctorconsumers with kidney diseaseask a doctor

Other Information

  • Safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing store between 20°and 25°C (68°and 77°F) protect from excessive moisture and light

Inactive Ingredients

Anhydrous lactose, colloidal silicon dioxide, corn starch,croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol 400, pregelatinized corn starch, red iron oxide, steric acid, titanium dioxide, and yellow iron oxide,

* Please review the disclaimer below.