NDC 76168-095 Ibuprofen

Ibuprofen

NDC Product Code 76168-095

NDC Code: 76168-095

Proprietary Name: Ibuprofen 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: Ibuprofen 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):
BROWN (C48332)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
IBU200
Score: 1

NDC Code Structure

  • 76168 - Velocity Pharma
    • 76168-095 - Ibuprofen

NDC 76168-095-20

Package Description: 200 CARTON in 1 BOTTLE > 1 TABLET, COATED in 1 CARTON

NDC 76168-095-24

Package Description: 24 CARTON in 1 BOTTLE > 1 TABLET, COATED in 1 CARTON

NDC 76168-095-30

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

NDC Product Information

Ibuprofen with NDC 76168-095 is a a human over the counter drug product labeled by Velocity Pharma. The generic name of Ibuprofen is ibuprofen. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Velocity Pharma

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

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.

Ibuprofen 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.

  • IBUPROFEN 200 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)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
  • POLYVINYL ALCOHOL (UNII: 532B59J990)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • 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: Velocity Pharma
Labeler Code: 76168
FDA Application Number: ANDA091239 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: 03-27-2019 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.

Ibuprofen 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) Ibuprofen 200 mg (NSAID)** nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily relieves minor aches and pains due to:headachetoothachebackachemenstrual crampsminor pains of arthritismuscular achesthe common coldtemporarily reduces fever

Warnings

  • Allergy alert: This product may cause a severe allergic reaction, especially in people allergic to aspirin, symptoms may include
  • Hivesfacial swellingasthma(wheezing)shockskin reddningrashblistersif an allergic reaction occurs, stop use and seek medical help right awayStomach bleeding warning: this product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
  • Are age 60 or olderhave had stomach ulcers or bleeding problemstake a blood thinning(anticoagulant) or steroid drug.take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen or others]have 3 or more alcoholic drinks every day while using this producttake more or for a longer time than directed.do not usethis product if you have ever had an allergic reaction to any pain reliever/fever reducerright before or after heart surgeryask your doctor before use ifstomach bleeding warning applies to youyou have problems or serious side effects from taking pain relievers or fever reducersyou have a history of stomach problems such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthmaask your doctor or pharmacist before use if you areunder a doctor’s care for any serious conditiontaking aspirin for heart attack or stroke, because ibuprofen may decrease the benefit of aspirintaking any other drugwhen using this producttake with food or milkThe risk of heart attack or stroke may increase if you are more than directed or for longer than directedStop use and ask a doctor if:you experience and of the following signs of stomach bleeding:feel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betterpain gets worse or lasts more than 10 daysfever gets worse or lasts more than 3 daysredness or swelling is present in the painful areaany new symptoms appearIf pregnant or breast-feeding, ask a health professional before use. it is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep Out Of Reach Of Children.

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

Directions

  • Do not take more than directedthe smallest effective dose should be used adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persists.If pain or fever does not respond to 1 tablet, 2 tablets may be useddo not exceed 6 tablets in 24 hours, unless directed by a doctorchildren under 12 years: ask a doctor

Other Information

  • Read all warnings and directions before use. keep cartonstore at 20-25 °C (68-77 °F)avoid excessive heat above 40°C (104°F)do not use if imprinted safety seal under the cap is broken or missing

Inactive Ingredients

Colloidal silicon Dioxide, corn starch, Croscarmellose Sodium, hypermellose, Iron Oxide red, lactose monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, povidone, Pregelatinized Starch, stearic acid, Talc, Titanium Dioxide, triacetin

* Please review the disclaimer below.

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