NDC 16714-899 Fexofenadine Hcl

Fexofenadine Hcl

NDC Product Code 16714-899

NDC Code: 16714-899

Proprietary Name: Fexofenadine Hcl 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 Hcl 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

  • 16714 - Northstar Rxllc
    • 16714-899 - Fexofenadine Hcl

NDC 16714-899-01

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

NDC 16714-899-02

Package Description: 1 BOTTLE in 1 CARTON > 100 TABLET in 1 BOTTLE

NDC Product Information

Fexofenadine Hcl with NDC 16714-899 is a a human over the counter drug product labeled by Northstar Rxllc. The generic name of Fexofenadine Hcl is fexofenadine hcl. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Northstar Rxllc

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 Hcl 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)
  • HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • TALC (UNII: 7SEV7J4R1U)
  • 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: Northstar Rxllc
Labeler Code: 16714
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: 02-18-2019 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 Hcl 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) In Each Tablet

Fexofenadine hydrochloride USP, 180 mg

Purpose

Antihistamine

Use(S)

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 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 directed §       do not take at the same time as aluminum or magnesium antacids§ do 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 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 Information

• Tamper-Evident: Do not use if printed foil seal under cap is missing • store between 20° and 25°C (68° and 77°F) • protect from excessive moisture

Inactive Ingredients

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.

Questions?

Call 1-800-206-7821Manufactured for: Northstar Rx LLC Memphis, TN 38141. Manufactured by: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar - 509 301, India. Mfg. Lic. No.: 50/MN/AP/2009/F/R Issued: 11/2018

* Please review the disclaimer below.

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