NDC 62207-765 Fexofenadine Hydrochloride

Fexofenadine Hydrochloride

NDC Product Code 62207-765

NDC CODE: 62207-765

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: OVAL (C48345)
Size(s):
12 MM
Imprint(s):
G5
Score: 1

NDC Code Structure

NDC 62207-765-49

Package Description: 1000 TABLET in 1 BOTTLE

NDC 62207-765-51

Package Description: 1 BOTTLE in 1 CARTON > 10 TABLET in 1 BOTTLE

NDC 62207-765-60

Package Description: 8 BLISTER PACK in 1 CARTON > 9 TABLET in 1 BLISTER PACK

NDC Product Information

Fexofenadine Hydrochloride with NDC 62207-765 is a a human over the counter drug product labeled by Granules India Ltd. The generic name of Fexofenadine Hydrochloride is fexofenadine hydrochloride. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Granules India Ltd

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 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.

  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • 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.
  • 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: Granules India Ltd
Labeler Code: 62207
FDA Application Number: ANDA211075 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: 11-01-2019 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 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(S)

Fexofenadine HCl USP 60 mg (for 60 mg)


Fexofenadine HCl USP 180 mg (for 180 mg)

Purpose

Antihistamine

Use(S)

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny noseitchy, water eyessneezingitching of the nose or throat

Warnings

  • 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 productdo 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 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.

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 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours (for 60 mg)


take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours (for 180 mg) 


 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 Information

  • Safety-sealed: do not use if foil printed with granules logo under bottle cap is opened or torn.Do not use if carton is opened or if individual blister units are torn or opened.store between 20º and 25ºC (68º and 77ºF)protect from excessive moisture

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide.

* Please review the disclaimer below.