One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. For unapproved drugs, this field will be null. 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. This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated.
Name of Company corresponding to the labeler code segment of the Product NDC.įDA Application Number: ANDA079174 What is the FDA Application Number? Product Labeler Information What is the Labeler Name? Nonsteroidal Anti-inflammatory Drug - (Established Pharmacologic Class).Cyclooxygenase Inhibitors - (Mechanism of Action).Anti-Inflammatory Agents, Non-Steroidal.These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. Pharmacologic Class(es) What is a Pharmacological Class?
If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. This effect helps to decrease swelling, pain, or fever. It works by blocking your body's production of certain natural substances that cause inflammation. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). It is also used to reduce fever and to relieve minor aches and pain due to the common cold or flu. Ibuprofen is used to relieve pain from various conditions such as headache, dental pain, menstrual cramps, muscle aches, or arthritis.
Always ask a health care professional for complete information about this product and your specific health needs. This information is not individual medical advice and does not substitute for the advice of a health care professional. This information does not assure that this product is safe, effective, or appropriate. The drug use information is a summary and does NOT have all possible information about this product. Drug Use Information Drug Use Information The generic name usually includes the active ingredient(s) of the product. The non-proprietary name is sometimes called the generic name. Non-Proprietary Name: Ibuprofen What is the Non-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. Proprietary Name: Ibuprofen What is the Proprietary Name?