NDC 68210-0122 Fexofenadine Hydrochloride

Fexofenadine Hydrochloride

NDC Product Code 68210-0122

NDC Code: 68210-0122

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)
Shape: CAPSULE (C48336)
Size(s):
17 MM
Imprint(s):
180
Score: 1

NDC Code Structure

  • 68210 - Spirit Pharmaceuticals Llc
    • 68210-0122 - Fexofenadine Hydrochloride

NDC 68210-0122-1

Package Description: 100 TABLET in 1 BOTTLE

NDC Product Information

Fexofenadine Hydrochloride with NDC 68210-0122 is a a human over the counter drug product labeled by Spirit Pharmaceuticals Llc. The generic name of Fexofenadine Hydrochloride is fexofenadine hydrochloride. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Spirit Pharmaceuticals Llc

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.

  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • 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: Spirit Pharmaceuticals Llc
Labeler Code: 68210
FDA Application Number: ANDA210137 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: 03-21-2019 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 180 mg

Purpose

Antihistamine

Uses

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

Otc - Do Not Use

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Otc - Ask Doctor

Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a


different dose.

Otc - 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)

Otc - Stop Use

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek


medical help right away. You may report side effects to FDA at


1-800-FDA-1088.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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 age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor

Other Safety Information

Other information  safety sealed: do not use if printed foil inner


seal on bottle is torn or missing  store between 20º and 25ºC (68º


and 77ºF)  protect from excessive moisture

Inactive Ingredient

Inactive ingredients colloidal silicone dioxide, croscarmellose sodium, hypromellose,


magnesium stearate, microcrystalline cellulose, polyethylene


glycol/macrogol, povidone, pregelatinized starch, red iron oxide,


silica, titanium dioxide, yellow iron oxide.

Otc - Questions

Questions or comments? call


+1-888-333-9792

Other

Distributed by:


Spirit Pharmaceuticals LLC,


Ronkonkoma, NY 11779


ORG 03/19Manufactured by:


Unique Pharmaceutical


Laboratories


(A Div. of J. B. Chemicals &


Pharmaceuticals Ltd.)


Mumbai 400 030, India


Mfg. Lic. No.: G/1430

* Please review the disclaimer below.

Previous Code
68210-0120
Next Code
68210-0130