NDC 41250-520 Anti-diarrheal
Loperamide Hydrochloride Capsule, Liquid Filled Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Product Characteristics
Code Structure Chart
Product Details
What is NDC 41250-520?
What are the uses for Anti-diarrheal?
What are Anti-diarrheal Active Ingredients?
- LOPERAMIDE HYDROCHLORIDE 2 mg/1 - One of the long-acting synthetic ANTIDIARRHEALS; it is not significantly absorbed from the gut, and has no effect on the adrenergic system or central nervous system, but may antagonize histamine and interfere with acetylcholine release locally.
Which are Anti-diarrheal UNII Codes?
The UNII codes for the active ingredients in this product are:
- LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C)
- LOPERAMIDE (UNII: 6X9OC3H4II) (Active Moiety)
Which are Anti-diarrheal 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:
- BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
- GELATIN (UNII: 2G86QN327L)
- GLYCERIN (UNII: PDC6A3C0OX)
- GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
- POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
- WATER (UNII: 059QF0KO0R)
What is the NDC to RxNorm Crosswalk for Anti-diarrheal?
- RxCUI: 978006 - loperamide HCl 2 MG Oral Capsule
- RxCUI: 978006 - loperamide hydrochloride 2 MG Oral Capsule
Which are the Pharmacologic Classes for Anti-diarrheal?
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Patient Education
Loperamide
Nonprescription (over-the-counter) loperamide is used to control acute diarrhea (loose stools that come on suddenly and usually lasts less than 2 weeks), including travelers' diarrhea. Prescription loperamide is also used to control acute diarrhea and also ongoing diarrhea associated with inflammatory bowel disease (IBD; condition in which the lining of all or part of the intestine is swollen, irritated, or has sores). Prescription loperamide is also used to reduce the amount of fluid in people with ileostomies (surgery to create an opening for waste to leave the body through the abdomen). Loperamide is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel and by slowing down the movement of the bowel to decrease the number of bowel movements.
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[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".