69230-325 NDC - LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

Drug Information

  • Product NDC: 69230-325
  • Proprietary Name:
  • Non Proprietary Name: Loperamide Hydrochloride and Simethicone
  • Active Ingredient(s): 125 mg/1 DIMETHICONE; 2 mg/1 LOPERAMIDE HYDROCHLORIDE125 mg/1 DIMETHICONE; 2 mg/1 LOPERAMIDE HYDROCHLORIDE
  • Administration Route(s):
  • Dosage Form(s): TABLET
  • Pharmacy Class(es): Opioid Agonist [EPC]; Opioid Agonists [MoA]; Skin Barrier Activity [PE]

Labeler Information

Field Name Field Value
Labeler Name: Camber Consumer Care Inc
Product Type: DRUG FOR FURTHER PROCESSING
FDA Application Number:
Marketing Category: DRUG FOR FURTHER PROCESSING
Start Marketing Date:6/17/2021

Package Information

No. Package Code Package Description Billing Unit
169230-325-0010 POUCH in 1 DRUM (69230-325-00) / 1000 TABLET in 1 POUCH
269230-325-041 BLISTER PACK in 1 CARTON (69230-325-04) / 4 TABLET in 1 BLISTER PACK
369230-325-061 BLISTER PACK in 1 CARTON (69230-325-06) / 6 TABLET in 1 BLISTER PACK
469230-325-082 BLISTER PACK in 1 CARTON (69230-325-08) / 4 TABLET in 1 BLISTER PACK
569230-325-122 BLISTER PACK in 1 CARTON (69230-325-12) / 6 TABLET in 1 BLISTER PACKEA
669230-325-183 BLISTER PACK in 1 CARTON (69230-325-18) / 6 TABLET in 1 BLISTER PACK
769230-325-244 BLISTER PACK in 1 CARTON (69230-325-24) / 6 TABLET in 1 BLISTER PACKEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC69230-325The 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.
NON PROPRIETARY NAMELoperamide Hydrochloride and SimethiconeThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLETThe translation of the dosage form Code submitted by the firm.
START MARKETING DATE6/17/2021This 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.
LABELER NAMECamber Consumer Care IncName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEDIMETHICONE; LOPERAMIDE 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 STRENGTH125; 2 
ACTIVE INGRED UNITmg/1; mg/1 
PRODUCT NDC69230-325The 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 NAMEDRUG FOR FURTHER PROCESSINGIndicates 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.
NON PROPRIETARY NAMELoperamide Hydrochloride and SimethiconeThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLETThe translation of the dosage form Code submitted by the firm.
START MARKETING DATE6/17/2021This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEDRUG FOR FURTHER PROCESSINGProduct 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.
LABELER NAMECamber Consumer Care IncName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEDIMETHICONE; LOPERAMIDE 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 STRENGTH125; 2 
ACTIVE INGRED UNITmg/1; mg/1 

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This page was last updated on: 11/21/2025

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