NDC 72189-305 Fexofenadine

Fexofenadine

NDC Product Code 72189-305

NDC CODE: 72189-305

Proprietary Name: Fexofenadine 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 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: CAPSULE (C48336)
Size(s):
18 MM
Imprint(s):
J;44
Score: 1

NDC Code Structure

NDC 72189-305-30

Package Description: 30 TABLET in 1 BOTTLE

NDC Product Information

Fexofenadine with NDC 72189-305 is a a human over the counter drug product labeled by Directrx. The generic name of Fexofenadine is fexofenadine. The product's dosage form is tablet and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 997420.

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 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.


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.

  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • TALC (UNII: 7SEV7J4R1U)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)

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: Directrx
Labeler Code: 72189
FDA Application Number: ANDA204097 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: 12-17-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Fexofenadine Product Label Images

Fexofenadine 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

Otc - Active Ingredient

Fexofenadine hydrochloride USP, 180 mg

Otc - Purpose

Antihistamine

Otc - When Using

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

§ 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)

Otc - Do Not Use

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

Otc - Ask Doctor/Pharmacist

You have kidney disease. Your doctor should determine if you need a different dose.

Otc - Stop Use

An allergic reaction to this product occurs. Seek medical help right away.If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

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

Other Safety Information

 Safety Sealed: do not use if carton is opened or if printed foil inner seal on the bottle is torn or missing.

 store between 20° and 25°C (68° and 77°F)

 protect from excessive moisture

Inactive Ingredient

Colloidal silicon dioxide, hypromellose, light liquid paraffin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.

Otc - Questions

Call toll-free weekdays 9 AM to 5 PM EST at 1-888-588-1418

* Please review the disclaimer below.