NDC 75987-010 Duexis
Ibuprofen And Famotidine Tablet, Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Product Characteristics
Code Structure Chart
Product Details
What is NDC 75987-010?
What are the uses for Duexis?
What are Duexis Active Ingredients?
- FAMOTIDINE 26.6 mg/1 - A competitive histamine H2-receptor antagonist. Its main pharmacodynamic effect is the inhibition of gastric secretion.
- IBUPROFEN 800 mg/1 - A non-steroidal anti-inflammatory agent with analgesic, antipyretic, and anti-inflammatory properties
Which are Duexis UNII Codes?
The UNII codes for the active ingredients in this product are:
- IBUPROFEN (UNII: WK2XYI10QM)
- IBUPROFEN (UNII: WK2XYI10QM) (Active Moiety)
- FAMOTIDINE (UNII: 5QZO15J2Z8)
- FAMOTIDINE (UNII: 5QZO15J2Z8) (Active Moiety)
Which are Duexis Inactive Ingredients UNII Codes?
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. The UNII codes for the inactive ingredients in this product are:
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- WATER (UNII: 059QF0KO0R)
- POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
- POLYSORBATE 80 (UNII: 6OZP39ZG8H)
- POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
- HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
- TALC (UNII: 7SEV7J4R1U)
- FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
What is the NDC to RxNorm Crosswalk for Duexis?
- RxCUI: 1100066 - ibuprofen 800 MG / famotidine 26.6 MG Oral Tablet
- RxCUI: 1100066 - famotidine 26.6 MG / ibuprofen 800 MG Oral Tablet
- RxCUI: 1100070 - DUEXIS 800 MG / 26.6 MG Oral Tablet
- RxCUI: 1100070 - famotidine 26.6 MG / ibuprofen 800 MG Oral Tablet [Duexis]
- RxCUI: 1100070 - Duexis (famotidine 26.6 MG / ibuprofen 800 MG) Oral Tablet
Which are the Pharmacologic Classes for Duexis?
- Anti-Inflammatory Agents, Non-Steroidal - [CS]
- Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
- Histamine H2 Receptor Antagonists - [MoA] (Mechanism of Action)
- Histamine-2 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
* Please review the disclaimer below.
Patient Education
Famotidine
Prescription famotidine is used to treat ulcers (sores on the lining of the stomach or small intestine); gastroesophageal reflux disease (GERD, a condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus [tube that connects the mouth and stomach]); and conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome (tumors in the pancreas or small intestine that cause increased production of stomach acid). Over-the-counter famotidine is used to prevent and treat heartburn due to acid indigestion and sour stomach caused by eating or drinking certain foods or drinks. Famotidine is in a class of medications called H2 blockers. It works by decreasing the amount of acid made in the stomach.
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Ibuprofen
Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). It is also used to relieve mild to moderate pain, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription ibuprofen is used to reduce fever and to relieve minor aches and pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Ibuprofen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.
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* Please review the disclaimer below.
[1] 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.
[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
[3] 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.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] 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.
[8] 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.
[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.
[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
[12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".