NDC 59556-959 Loperamide Hydrochloride

Loperamide Hydrochloride

NDC Product Code 59556-959

NDC CODE: 59556-959

Proprietary Name: Loperamide Hydrochloride What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Loperamide Hydrochloride 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.

Product Characteristics

Color(s):
BLUE (C48333)
Shape: OVAL (C48345)
Size(s):
10 MM
Imprint(s):
L2
Score: 1

NDC Code Structure

NDC 59556-959-05

Package Description: 2 BLISTER PACK in 1 CARTON > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (59556-959-03)

NDC 59556-959-06

Package Description: 1 BLISTER PACK in 1 CARTON > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (59556-959-03)

NDC Product Information

Loperamide Hydrochloride with NDC 59556-959 is a a human over the counter drug product labeled by Strides Pharma Inc. The generic name of Loperamide Hydrochloride is loperamide hydrochloride. The product's dosage form is capsule, liquid filled and is administered via oral form.

Dosage Form: Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.

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.

  • BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • SHELLAC (UNII: 46N107B71O)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: Strides Pharma Inc
Labeler Code: 59556
FDA Application Number: ANDA213070 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: 10-22-2021 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: 12-31-2022 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".

* Please review the disclaimer below.

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 acute diarrhea (loose stools that come on suddenly and usually lasts less than 2 weeks), including travel...
[Read More]

* Please review the disclaimer below.

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 Capsule)

Loperamide Hydrochloride USP, 2 mg

Purpose

Anti-diarrheal

Use

Controls symptoms of diarrhea, including Travelers' Diarrhea

Warnings

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HClHeart alert: Taking more than directed can cause serious heart problems or death

Do Not Use

  • If you have bloody or black stoolin children under 12 years of age

Ask A Doctor Before Use If You Have

  • Fevermucus in stoola history of liver diseasea history of abnormal heart rhythm

Ask A Doctor Or Pharmacist Before Use If You Are

Taking a prescription drug. Loperamide may interact with certain prescription drugs.

When Using This Product

Tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.

Stop Use And Ask A Doctor If

  • Symptoms get worsediarrhea lasts for more than 2 daysyou get abdominal swelling or bulging. These may be signs of a serious condition.

If 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

  • Drink plenty of clear fluids to help prevent dehydration caused by diarrhea.not for use in children under 12 years of ageadults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

Other Information

  • Store at 20°-25°C (68°-77°F). Protect from Light.avoid excessive heat above 40°C (104°F)do not use if carton or blister unit is open or tornsee side panel for lot number and expiration date

Inactive Ingredients

Butylated hydroxyanisole, FD&C Blue #1, gelatin, glycerol, glyceryl mono caprylo caprate, polyoxyl 40 hydrogenated castor oil, purified water,printing ink white-edible oil – dewaxed bleached shellac resins, propylene glycol, sodium lauryl sulphate, titanium dioxide.

* Please review the disclaimer below.