NDC 0480-4138 Lubiprostone
Capsule, Gelatin Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Product Characteristics
ORANGE (C48331 - CLEAR ORANGE)
A04
Code Structure Chart
Product Details
What is NDC 0480-4138?
What are the uses for Lubiprostone?
What are Lubiprostone Active Ingredients?
- LUBIPROSTONE 24 ug/1 - Member of a bicyclic fatty acid class of compounds derived from PROSTAGLANDIN E1 involved in chloride channel gating.
Which are Lubiprostone UNII Codes?
The UNII codes for the active ingredients in this product are:
- LUBIPROSTONE (UNII: 7662KG2R6K)
- LUBIPROSTONE (UNII: 7662KG2R6K) (Active Moiety)
Which are Lubiprostone 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:
- FERROSOFERRIC OXIDE (UNII: XM0M87F357)
- FERRIC OXIDE RED (UNII: 1K09F3G675)
- GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
- HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
- LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
- MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- WATER (UNII: 059QF0KO0R)
- SORBITOL SOLUTION (UNII: 8KW3E207O2)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
- FD&C RED NO. 40 (UNII: WZB9127XOA)
What is the NDC to RxNorm Crosswalk for Lubiprostone?
- RxCUI: 616578 - lubiprostone 24 MCG Oral Capsule
- RxCUI: 616578 - lubiprostone 0.024 MG Oral Capsule
- RxCUI: 794639 - lubiprostone 8 MCG Oral Capsule
- RxCUI: 794639 - lubiprostone 0.008 MG Oral Capsule
Which are the Pharmacologic Classes for Lubiprostone?
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Patient Education
Lubiprostone
Lubiprostone is used to relieve stomach pain, bloating, and straining and produce softer and more frequent bowel movements in people who have chronic idiopathic constipation (difficult or infrequent passage of stools that lasts for 3 months or longer and is not caused by a disease or a medication). Lubiprostone is also used to treat irritable bowel syndrome with constipation (IBS-C; a condition that causes stomach pain or cramps, bloating, and infrequent or difficult passage of stools) in women who are at least 18 years of age. Lubiprostone is also used to treat constipation caused by certain opioid (narcotic) pain medications in people with chronic (on-going), noncancer pain. Lubiprostone is in a class of medications called laxatives. It works by increasing the amount of fluid that flows into the bowel and allowing the stool to pass more easily.
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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".