NDC 69230-325 Loperamide Hydrochloride And Simethicone

Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
69230-325
Proprietary Name:
Loperamide Hydrochloride And Simethicone
Non-Proprietary Name: [1]
Loperamide Hydrochloride And Simethicone
Substance Name: [2]
Dimethicone; Loperamide Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Camber Consumer Care Inc
    Labeler Code:
    69230
    FDA Application Number: [6]
    ANDA211438
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    06-17-2021
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)
    Shape:
    CAPSULE (C48336)
    Size(s):
    17 MM
    Imprint(s):
    H;L21
    Score:
    2
    Flavor(s):
    VANILLA (C73421)

    Product Packages

    NDC Code 69230-325-04

    Package Description: 1 BLISTER PACK in 1 CARTON / 4 TABLET in 1 BLISTER PACK

    NDC Code 69230-325-06

    Package Description: 1 BLISTER PACK in 1 CARTON / 6 TABLET in 1 BLISTER PACK

    NDC Code 69230-325-08

    Package Description: 2 BLISTER PACK in 1 CARTON / 4 TABLET in 1 BLISTER PACK

    NDC Code 69230-325-12

    Package Description: 2 BLISTER PACK in 1 CARTON / 6 TABLET in 1 BLISTER PACK

    Price per Unit: $0.27463 per EA

    NDC Code 69230-325-18

    Package Description: 3 BLISTER PACK in 1 CARTON / 6 TABLET in 1 BLISTER PACK

    NDC Code 69230-325-24

    Package Description: 4 BLISTER PACK in 1 CARTON / 6 TABLET in 1 BLISTER PACK

    Price per Unit: $0.27463 per EA

    Product Details

    What is NDC 69230-325?

    The NDC code 69230-325 is assigned by the FDA to the product Loperamide Hydrochloride And Simethicone which is a human over the counter drug product labeled by Camber Consumer Care Inc. The product's dosage form is tablet and is administered via oral form. The product is distributed in 6 packages with assigned NDC codes 69230-325-04 1 blister pack in 1 carton / 4 tablet in 1 blister pack, 69230-325-06 1 blister pack in 1 carton / 6 tablet in 1 blister pack, 69230-325-08 2 blister pack in 1 carton / 4 tablet in 1 blister pack, 69230-325-12 2 blister pack in 1 carton / 6 tablet in 1 blister pack, 69230-325-18 3 blister pack in 1 carton / 6 tablet in 1 blister pack, 69230-325-24 4 blister pack in 1 carton / 6 tablet in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Loperamide Hydrochloride And Simethicone?

    •  drink plenty of clear fluids to help prevent dehydration caused by diarrhea • take only on an empty stomach (1 hour before or 2 hours after a meal) • take with a full (8 oz.) glass of water • find right dose on chart below. If possible, use weight to dose; otherwise, use age. adults and children 12 years and over 2 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours children 9-11 years (60-95 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours children 6-8 years (48-59 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets in  24 hours children 2-5 years (34 to 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use

    What are Loperamide Hydrochloride And Simethicone Active Ingredients?

    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.
    • DIMETHICONE 125 mg/1
    • 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 Loperamide Hydrochloride And Simethicone UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Loperamide Hydrochloride And Simethicone 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:

    What is the NDC to RxNorm Crosswalk for Loperamide Hydrochloride And Simethicone?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 978001 - loperamide HCl 2 MG / simethicone 125 MG Oral Tablet
    • RxCUI: 978001 - loperamide hydrochloride 2 MG / simethicone 125 MG Oral Tablet

    Which are the Pharmacologic Classes for Loperamide Hydrochloride And Simethicone?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    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.
    [Learn More]


    Simethicone


    Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [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".