NDC 0904-6711 Fexofenadine Hydrochloride

Fexofenadine Hydrochloride

NDC Product Code 0904-6711

NDC Code: 0904-6711

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):
PINK (C48328)
Shape: OVAL (C48345)
Size(s):
7 MM
Imprint(s):
194;R
Score: 1

NDC Code Structure

NDC 0904-6711-10

Package Description: 3 BLISTER PACK in 1 CARTON > 5 TABLET in 1 BLISTER PACK

NDC 0904-6711-46

Package Description: 1 BOTTLE in 1 CARTON > 30 TABLET in 1 BOTTLE

NDC 0904-6711-52

Package Description: 2 BOTTLE in 1 CARTON > 30 TABLET in 1 BOTTLE

NDC 0904-6711-89

Package Description: 1 BOTTLE in 1 CARTON > 90 TABLET in 1 BOTTLE

NDC 0904-6711-92

Package Description: 1 BOTTLE in 1 CARTON > 150 TABLET in 1 BOTTLE

NDC Product Information

Fexofenadine Hydrochloride with NDC 0904-6711 is a a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Fexofenadine Hydrochloride is fexofenadine hydrochloride. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Major Pharmaceuticals

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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 180 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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MANNITOL (UNII: 3OWL53L36A)
  • POWDERED CELLULOSE (UNII: SMD1X3XO9M)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • STARCH, CORN (UNII: O8232NY3SJ)

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: Major Pharmaceuticals
Labeler Code: 0904
FDA Application Number: ANDA076502 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: 04-27-2018 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.

Information for Patients

Fexofenadine

Fexofenadine is pronounced as (fex oh fen' a deen)

Why is fexofenadine medication prescribed?
Fexofenadine is used to relieve the allergy symptoms of seasonal allergic rhinitis (''hay fever''), including runny nose; sneezing; red, itchy, or watery eyes; or itching...
[Read More]

* 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, 180 mg

Purpose

Antihistamine

Uses

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nose itchy, watery eyessneezingitching 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 aluminum 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 over         take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hourschildren 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 missingstore between 20° and 25°C (68° and 77°F)protect from excessive moisturethis product meets the requirements of USP Dissolution Test 4

Inactive Ingredients

Colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titantium dioxide

Questions?

Call 1-888-375-3784

Package Label - 30 Count Carton

  • MAJOR COMPARE TO active ingredient of ALLEGRA® ALLERGY 24 HOUR TABLETS*NDC 0904-6711-46Original Prescription StrengthFEXOFENADINE HYDROCHLORIDE Tablets USP, 180 mg AntihistamineALLERGY Relief of:SneezingRunny Nose Itchy, Watery EyesItchy Nose or ThroatNon-DrowsyIndoor & Outdoor Allergies24 HOUR30 TABLETS 180 mg EACH

Package Label - 30 Count Bottle

MAJOR NDC 0904-6711-46Original Prescription StrengthFEXOFENADINE HYDROCHLORIDE Tablets USP, 180 mg / AntihistamineALLERGY Indoor & Outdoor AllergiesNon-Drowsy24 HOUR30 TABLETS 180 mg EACH

* Please review the disclaimer below.