NDC 50383-618 Loperamide Hydrochloride

Loperamide Hydrochloride

NDC Product Code 50383-618

NDC 50383-618-04

Package Description: 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE

Price per Unit: $0.01962 per ML

NDC 50383-618-06

Package Description: 4 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (50383-618-05)

NDC 50383-618-11

Package Description: 4 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (50383-618-10)

NDC Product Information

Loperamide Hydrochloride with NDC 50383-618 is a a human over the counter drug product labeled by Hi-tech Pharmacal Co., Inc.. The generic name of Loperamide Hydrochloride is loperamide hydrochloride. The product's dosage form is solution and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 977986.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Otc Drug 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.

Loperamide Hydrochloride Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • ALCOHOL (UNII: 3K9958V90M)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • CHERRY (UNII: BUC5I9595W)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MINT (UNII: FV98Z8GITP)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITOL (UNII: 506T60A25R)
  • SUCROSE (UNII: C151H8M554)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Hi-tech Pharmacal Co., Inc.
Labeler Code: 50383
FDA Application Number: ANDA074352 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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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.

Start Marketing Date: 11-17-1995 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 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.

Exclude Flag: N - NO 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".

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Information for Patients

Loperamide

Loperamide is pronounced as (loe per' a mide)

Why is loperamide medication prescribed?
Nonprescription (over-the-counter) loperamide is used to control diarrhea, including travelers' diarrhea. Prescription loperamide is used to control diarrhea, including o...
[Read More]

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Loperamide Hydrochloride Product Label Images

Loperamide Hydrochloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

(in each 5 mL teaspoonful)Loperamide HCl 1 mg

Purpose

Antidiarrheal

Uses

  • Controls the symptoms of diarrhea, including Traveler's Diarrhea

Warnings

  • Alergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HClDo not use if you have bloody or black stoolAsk a doctor before use if you havehigh fever (greater than 101°F)mucus present in your stoola history of liver diseaseAsk doctor or pharmacist before use if you are taking antibioticsStop use and ask a doctor if diarrhea lasts for more than 2 daysIf pregnant or breast-feeding, ask a health professional before use

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Use enclosed dosage cup to accurately measure dosage as noted belowdrink plenty of clear fluids to help prevent dehydration, which may accompany diarrheafind right dose on chart. If possible, use weight to dose; otherwise, use age.adults and children 12 years and older4 teaspoonfuls (1 dosage cup) after the first loose bowel movement; 2 teaspoonfuls (1/2 dosage cup) after each subsequent loose bowel movement; but no more than 8 teaspoonfuls a daychildren 9-11 years (60-95 lbs)2 teaspoonfuls (1/2 dosage cup) after the first loose bowel movement; 1 teaspoonful (1/4 dosage cup) after each subsequent loose bowel movement; but no more than 6 teaspoonfuls a daychildren 6-8 years (48-59 lbs)2 teaspoonfuls (1/2 dosage cup) after the first loose bowel movement; 1 teaspoonful (1/4 dosage cup) after each subsequent loose bowel movement; but no more than 4 teaspoonfuls a daychildren under 6 years (up to 47 lbs)ask a doctor (not intended for use in children under 6 years old)

Other Information

  • Avoid excess heatstore at room temperature, 15° - 30°C (59° - 86°F)

Inactive Ingredients

Alcohol (0.5%), benzoic acid, cherry flavor, glycerin, mint flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose. Citric acid may be used to adjust pH

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