NDC 69842-807

loperamide hydrochloride and simethicone

Loperamide Hydrochloride, Simethicone

loperamide hydrochloride and simethicone is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Cvs Pharmacy. The primary component is Dimethicone; Loperamide Hydrochloride.

Product ID69842-807_005cc87d-19ba-4fe3-aa68-a460e81b7d3a
NDC69842-807
Product TypeHuman Otc Drug
Proprietary Nameloperamide hydrochloride and simethicone
Generic NameLoperamide Hydrochloride, Simethicone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-10-08
Marketing CategoryANDA / ANDA
Application NumberANDA209837
Labeler NameCVS Pharmacy
Substance NameDIMETHICONE; LOPERAMIDE HYDROCHLORIDE
Active Ingredient Strength125 mg/1; mg/1
Pharm ClassesOpioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 69842-807-53

12 BLISTER PACK in 1 CARTON (69842-807-53) > 1 TABLET in 1 BLISTER PACK
Marketing Start Date2018-10-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69842-807-65 [69842080765]

loperamide hydrochloride and simethicone TABLET
Marketing CategoryANDA
Application NumberANDA209837
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-10-16

NDC 69842-807-53 [69842080753]

loperamide hydrochloride and simethicone TABLET
Marketing CategoryANDA
Application NumberANDA209837
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-10-08

Drug Details

Active Ingredients

IngredientStrength
LOPERAMIDE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:2ad0645a-756e-4179-bc7b-4085253dc2b2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 978001

    • NDC Crossover Matching brand name "loperamide hydrochloride and simethicone" or generic name "Loperamide Hydrochloride, Simethicone"

    NDCBrand NameGeneric Name
    0363-9606Loperamide Hydrochloride and SimethiconeLoperamide Hydrochloride and Simethicone
    58602-815Loperamide Hydrochloride and SimethiconeLoperamide Hydrochloride and Simethicone
    69842-807loperamide hydrochloride and simethiconeloperamide hydrochloride and simethicone
    0363-1830anti diarrheal and anti gasloperamide hydrochloride, simethicone
    11822-1003anti diarrheal anti gasloperamide hydrochloride, simethicone
    30142-581Anti Diarrheal Anti GasLoperamide Hydrochloride, Simethicone
    37808-714anti diarrheal anti gasloperamide hydrochloride, simethicone
    46122-566Anti Diarrheal Anti Gasloperamide hydrochloride, simethicone
    41250-375anti diarrheal plus anti gasloperamide hydrochloride, simethicone
    56062-511antidiarrheal multi symptom reliefloperamide hydrochloride, simethicone
    0113-7119basic care loperamide hydrochloride and simethiconeloperamide hydrochloride, simethicone
    41520-772CareOne Diarrhea and Gas Controlloperamide hydrochloride, simethicone
    55910-383dg health anti diarrheal anti gasloperamide hydrochloride, simethicone
    41163-553equaline anti diarrheal plus anti gasloperamide hydrochloride, simethicone
    49035-549equate anti diarrheal anti gasloperamide hydrochloride, simethicone
    55319-823family wellness anti diarrheal plus anti gasloperamide hydrochloride, simethicone
    55319-106family wellness anti diarrheal plus multi symptom reliefloperamide hydrochloride, simethicone
    46122-620good neighbor pharmacy anti diarrheal anti gasloperamide hydrochloride, simethicone
    0113-0087good sense anti diarrheal anti gasloperamide hydrochloride, simethicone
    0113-1087Good Sense Anti Diarrheal Anti Gasloperamide hydrochloride, simethicone
    53041-263Loperamide Hydrochloride, SimethiconeLoperamide Hydrochloride, Simethicone
    21130-183signature care anti diarrheal anti gasloperamide hydrochloride, simethicone
    36800-633topcare anti diarrheal anti gasloperamide hydrochloride, simethicone
    11673-646up and up anti diarrheal anti gasloperamide hydrochloride, simethicone
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