41520-813 NDC - CAREONE DIARRHEA CONTROL (LOPERAMIDE HCL)

Drug Information

Product NDC: 41520-813

Proprietary Name: CareOne Diarrhea Control

Non Proprietary Name: Loperamide HCl

Active Ingredient(s):
  • 2 mg/1 LOPERAMIDE HYDROCHLORIDE


Administration Route(s): ORAL

Dosage Form(s): TABLET, FILM COATED

Pharmacy Class(es):
  • Opioid Agonist [EPC];
  • Opioid Agonists [MoA]

Labeler Information

Labeler Name: American Sales Company
Product Type: HUMAN OTC DRUG
FDA Application Number: ANDA075232
Marketing Category: ANDA
Start Marketing Date:9/14/2016

Package Information

No. Package Code Package Description Billing Unit
141520-813-5312 BLISTER PACK in 1 CARTON (41520-813-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK
241520-813-6224 BLISTER PACK in 1 CARTON (41520-813-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK
341520-813-671 BOTTLE in 1 CARTON (41520-813-67) / 48 TABLET, FILM COATED in 1 BOTTLE

NDC Record

Field Name Field Value Definition
PRODUCT NDC41520-813The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates 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.
PROPRIETARY NAMECareOne Diarrhea ControlThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMELoperamide HClThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, FILM COATEDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE9/14/2016This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct 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.
APPLICATION NUMBERANDA075232This 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.
LABELER NAMEAmerican Sales CompanyName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMELOPERAMIDE HYDROCHLORIDEAn 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.
ACTIVE NUMERATOR STRENGTH2 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESOpioid Agonist [EPC], Opioid Agonists [MoA] 

Download Record

Download this NDC record in Text format: Export

Download this NDC record in Excel (CSV) format: Export

Download this NDC record in XML format: Export

This page was last updated on: 2/1/2023