NDC 53113-657

Gadavyt Loperamide HCl

Loperamide Hydrochloride

Gadavyt Loperamide HCl is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Gadal Laboratories Inc. The primary component is Loperamide Hydrochloride.

Product ID53113-657_7aa6375e-6789-4465-967b-9d3ddeac3635
NDC53113-657
Product TypeHuman Otc Drug
Proprietary NameGadavyt Loperamide HCl
Generic NameLoperamide Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2013-05-01
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameGadal Laboratories Inc
Substance NameLOPERAMIDE HYDROCHLORIDE
Active Ingredient Strength1 mg/5mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 53113-657-04

1 BOTTLE in 1 CARTON (53113-657-04) > 118 mL in 1 BOTTLE
Marketing Start Date2013-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53113-657-04 [53113065704]

Gadavyt Loperamide HCl LIQUID
Marketing Categoryunapproved drug other
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-05-01
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
LOPERAMIDE HYDROCHLORIDE1 mg/5mL

OpenFDA Data

SPL SET ID:fa02a809-167c-4978-8226-6b42479b91e0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 977986

    • NDC Crossover Matching brand name "Gadavyt Loperamide HCl" or generic name "Loperamide Hydrochloride"

    NDCBrand NameGeneric Name
    53113-657Gadavyt Loperamide HClGadavyt Loperamide HCl
    0904-7725anti diarrhealLoperamide Hydrochloride
    30142-998Anti DiarrhealLoperamide Hydrochloride
    0363-0520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDE
    0363-1176Anti-DiarrhealLOPERAMIDE HYDROCHLORIDE
    11673-177Anti-DiarrhealLOPERAMIDE HYDROCHLORIDE
    11822-7834Anti-DiarrhealLOPERAMIDE HYDROCHLORIDE
    30142-159Anti-DiarrhealLOPERAMIDE HYDROCHLORIDE
    30142-520Anti-DiarrhealLOPERAMIDE HYDROCHLORIDE
    24385-554good neighbor pharmacy anti diarrhealLoperamide Hydrochloride
    0113-0224Good Sense anti diarrhealLoperamide Hydrochloride
    11673-520Loperamide HClLOPERAMIDE HYDROCHLORIDE
    0093-0311Loperamide HydrochlorideLoperamide Hydrochloride
    0378-2100Loperamide Hydrochlorideloperamide hydrochloride
    0615-0362Loperamide Hydrochlorideloperamide hydrochloride
    0615-8012Loperamide HydrochlorideLoperamide Hydrochloride
    0615-8087Loperamide Hydrochlorideloperamide hydrochloride
    15127-338Loperamide HydrochlorideLoperamide Hydrochloride
    17856-0618Loperamide HydrochlorideLoperamide Hydrochloride
    21695-692Loperamide HydrochlorideLoperamide Hydrochloride
    11673-224Up and Up anti diarrhealLoperamide Hydrochloride
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