NDC 55629-095 Ibuprofen

Ibuprofen

NDC Product Code 55629-095

NDC Code: 55629-095

Proprietary Name: Ibuprofen Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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

Code Structure
  • 55629 - One2zee Limited Liability Company
    • 55629-095 - Ibuprofen

NDC 55629-095-01

Package Description: 1 BAG in 1 BOX > 30000 TABLET in 1 BAG

NDC Product Information

Ibuprofen with NDC 55629-095 is a a human over the counter drug product labeled by One2zee Limited Liability Company. The generic name of Ibuprofen is ibuprofen. The product's dosage form is tablet and is administered via oral form.

Labeler Name: One2zee Limited Liability Company

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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)

Additional informationCallout TooltipWhat 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)

Additional informationCallout TooltipAbout 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)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIACETIN (UNII: XHX3C3X673)
  • TALC (UNII: 7SEV7J4R1U)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: One2zee Limited Liability Company
Labeler Code: 55629
FDA Application Number: ANDA079129 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 04-02-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Label Images

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

Otc - Active Ingredient Section

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

Otc - Purpose Section

Pain reliever / fever reducer

Indications And Usage

■    temporarily relieves minor aches and pains due to:                ■  headache                 ■  muscular aches                 ■  minor pain of arthritis                 ■  toothache                 ■  backache                 ■  the common cold                 ■  menstrual cramps■    temporarily reduces fever

Allergy Alert

  • Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:hivesfacial swellingrashblistersshockskin reddeningasthma (wheezing)If an allergic reaction occurs, stop use and seek medical help right away.

Stomach Bleeding Warning

  • This product contains a non-steroidal anti-inflammatory drug (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 drugtake 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 Use

  • If you have ever had an allergic reaction to any other pain reliever/fever reducerright before or after heart surgery

Ask A Doctor Before Use If

  • You have problems or serious side effects from taking pain relievers or fever reducersthe stomach bleeding warning applies to youyou have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseyou have asthmayou are taking a diuretic

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirinunder a doctor's care for any serious conditiontaking any other drug

When Using This Product

  • Take with food or milk if stomach upset occursthe risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop Use And Ask A Doctor If

■ you experience any of the following signs of stomach bleeding:                ■  feel faint                ■  vomit blood                ■  have bloody or black stools                ■  have stomach pain that does not get better■ pain gets worse or lasts more than 10 days■ fever gets worse or lasts more than 3 days■ redness or swelling is present in the painful area ■ any new symptoms appear

If 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 to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Otc - Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Dosage And Administration

  • Do not take more than directedthe smallest effective dose should be used adults and children 12 years and older ■ take 1 tablet every 4 to 6 hours while symptoms persist ■ if pain or fever does not respond to 1 tablet, 2 tablets may be used ■ do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years ■ ask a doctor

Storage And Handling

■ Store between 20-25°C (68-77°F)■ tamper evident: do not use if imprinted safety seal under cap is broken or missing;                                   do not use if seal is open or missing in bulk pack.

Inactive Ingredient

Colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, sodium starch glycolate, titanium dioxide, triacetin and talc

Otc - Questions

Call 1-732-465-0700: weekdays 8.00 AM to 8.00 PM

Other

Manufactured by:Strides Pharma Science LimitedPuducherry - 605014, IndiaSee New Warnings InformationIbuprofen Tablets USP 200 mgPain Reliever / Fever Reducer (NSAID)- 30000 coated tablets

* Please review the disclaimer below.

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