NDC 27241-202 Naproxen And Esomeprazole Magnesium
Tablet, Delayed Release Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 27241 - Ajanta Pharma Usa Inc.
- 27241-202 - Naproxen And Esomeprazole Magnesium
Product Characteristics
Product Packages
NDC Code 27241-202-60
Package Description: 60 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Details
What is NDC 27241-202?
What are the uses for Naproxen And Esomeprazole Magnesium?
What are Naproxen And Esomeprazole Magnesium Active Ingredients?
- ESOMEPRAZOLE MAGNESIUM 20 mg/1 - The S-isomer of omeprazole.
- NAPROXEN 375 mg/1 - An anti-inflammatory agent with analgesic and antipyretic properties. Both the acid and its sodium salt are used in the treatment of rheumatoid arthritis and other rheumatic or musculoskeletal disorders, dysmenorrhea, and acute gout.
Which are Naproxen And Esomeprazole Magnesium UNII Codes?
The UNII codes for the active ingredients in this product are:
- NAPROXEN (UNII: 57Y76R9ATQ)
- NAPROXEN (UNII: 57Y76R9ATQ) (Active Moiety)
- ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9)
- ESOMEPRAZOLE (UNII: N3PA6559FT) (Active Moiety)
Which are Naproxen And Esomeprazole Magnesium 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)
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
- TALC (UNII: 7SEV7J4R1U)
- TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
- HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
- POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
- SODIUM LAURYL SULFATE (UNII: 368GB5141J)
- MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
- FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
- SHELLAC (UNII: 46N107B71O)
- FERROSOFERRIC OXIDE (UNII: XM0M87F357)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- AMMONIA (UNII: 5138Q19F1X)
What is the NDC to RxNorm Crosswalk for Naproxen And Esomeprazole Magnesium?
- RxCUI: 994005 - naproxen 375 MG / esomeprazole magnesium 20 MG Delayed Release Oral Tablet
- RxCUI: 994005 - esomeprazole 20 MG / naproxen 375 MG Delayed Release Oral Tablet
- RxCUI: 994005 - esomeprazole (as esomeprazole magnesium) 20 MG / naproxen (as naproxen sodium) 375 MG Delayed Release Oral Tablet
- RxCUI: 994008 - naproxen 500 MG / esomeprazole magnesium 20 MG Delayed Release Oral Tablet
- RxCUI: 994008 - esomeprazole 20 MG / naproxen 500 MG Delayed Release Oral Tablet
Which are the Pharmacologic Classes for Naproxen And Esomeprazole Magnesium?
- Anti-Inflammatory Agents, Non-Steroidal - [CS]
- Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
- Cytochrome P450 2C19 Inhibitors - [MoA] (Mechanism of Action)
- Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
- Proton Pump Inhibitor - [EPC] (Established Pharmacologic Class)
- Proton Pump Inhibitors - [MoA] (Mechanism of Action)
* Please review the disclaimer below.
Patient Education
Esomeprazole
Prescription esomeprazole is used to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 1 year of age and older. Prescription esomeprazole is used to treat damage from GERD in adults and children 1 month of age and older. Prescription esomeprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults with GERD. Prescription esomeprazole is also used to decrease the chance that people who are taking nonsteroidal anti-inflammatory drugs (NSAIDs) will develop ulcers (sores in the lining of the stomach or intestine) in adults. It is also used with other medications to treat and prevent the return of stomach ulcers caused by a certain type of bacteria (H. pylori) in adults. Prescription esomeprazole is also used to treat conditions in which the stomach produces too much acid such as Zollinger-Ellison syndrome in adults. Nonprescription (over-the-counter) esomeprazole is used to treat frequent heartburn (heartburn that occurs at least 2 or more days a week) in adults. Esomeprazole is in a class of medications called proton pump inhibitors. It works by decreasing the amount of acid made in the stomach.
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Naproxen
Prescription naproxen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), juvenile arthritis (a form of joint disease in children), and ankylosing spondylitis (arthritis that mainly affects the spine). Prescription naproxen tablets, extended-release tablets, and suspension are also used to relieve shoulder pain caused by bursitis (inflammation of a fluid-filled sac in the shoulder joint), tendinitis (inflammation of the tissue that connects muscle to bone), gouty arthritis (attacks of joint pain caused by a build-up of certain substances in the joints), and pain from other causes, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription naproxen is used to reduce fever and to relieve mild pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Naproxen 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.
[11] 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.
[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".