NDC 11788-002 Ibuprofen

Ibuprofen

NDC Product Code 11788-002

NDC Code: 11788-002

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):
ORANGE (C48331)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
BI;02
Score: 1

Code Structure
  • 11788 - Aiping Pharmaceutical, Inc.
    • 11788-002 - Ibuprofen

NDC 11788-002-00

Package Description: 50864 TABLET, FILM COATED in 1 CARTON

NDC 11788-002-07

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

NDC 11788-002-10

Package Description: 1000 TABLET, FILM COATED in 1 BOTTLE

NDC Product Information

Ibuprofen with NDC 11788-002 is a a human over the counter drug product labeled by Aiping Pharmaceutical, Inc.. The generic name of Ibuprofen is ibuprofen. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Aiping Pharmaceutical, Inc.

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

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
  • 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)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
  • POLYVINYL ALCOHOL (UNII: 532B59J990)
  • STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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.
  • 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: Aiping Pharmaceutical, Inc.
Labeler Code: 11788
FDA Application Number: ANDA206990 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: 03-01-2019 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: 12-31-2019 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

Important

Read all product information before using. Keep this box for important information.

Other

Drug Facts

  • Allergy alertIbuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:hivesfacial swellingasthma (wheezing)shockskin reddeningrashblistersIf an allergic reaction occurs, stop use and seek medical help right away.

  • Stomach 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 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 directedHeart attack and stroke warning:NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.Brown Film-Coated Caplets contain FD+C Yellow No. 5 (tartrazine) as a color additive

Active Ingredient (In Each Caplet)

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

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily relieves minor aches and pains due to:
  • Headachemuscular achesminor pain of arthritistoothachebackachethe common coldmenstrual crampstemporarily reduces fever

Otc - Do Not Use

  • Do not useif you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducerright before or after heart surgery

Otc - Ask Doctor

  • Ask a doctor before use ifyou 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, kidney disease, asthma, or had a strokeyou are taking a diuretic

Otc - Ask Doctor/Pharmacist

  • Ask a doctor or pharmacist before use if you aretaking 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

Otc - When Using

  • When using this producttake with food or milk if stomach upset occurs

Otc - Stop Use

  • Stop use and ask a doctor ifyou experience any of the following signs of stomach bleeding:
  • Feel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betteryou have symptoms of heart problems or stroke:
  • Chest paintrouble breathingweakness in one part or side of bodyslurred speechleg swellingpain 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 appear

Otc - Pregnancy Or Breast Feeding

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

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

Directions

  • Do not take more than directedthe smallest effective dose should be usedadults and children 12 years and oldertake 1 caplet every 4 to 6 hours while symptoms persistif pain or fever does not respond to 1 caplet, 2 caplets may be useddo not exceed 6 caplets in 24 hours, unless directed by a doctorchildren under 12 yearsask a doctor

Other Information

  • Store between 20-25°C (68-77°F)do not use if the inner seal imprinted with "SEALED for YOUR PROTECTION" is broken or missing

* Please review the disclaimer below.

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