NDC 36800-645

topcare loperamide hydrochloride

Loperamide Hcl

topcare loperamide hydrochloride is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Loperamide Hydrochloride.

Product ID36800-645_c8a37884-9b52-46be-a0e5-f62c8d51a453
NDC36800-645
Product TypeHuman Otc Drug
Proprietary Nametopcare loperamide hydrochloride
Generic NameLoperamide Hcl
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2012-06-05
Marketing CategoryANDA / ANDA
Application NumberANDA091292
Labeler NameTopco Associates LLC
Substance NameLOPERAMIDE HYDROCHLORIDE
Active Ingredient Strength1 mg/7.5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 36800-645-26

120 mL in 1 BOTTLE (36800-645-26)
Marketing Start Date2012-06-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-645-26 [36800064526]

topcare loperamide hydrochloride SUSPENSION
Marketing CategoryANDA
Application NumberANDA091292
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2012-06-05

Drug Details

Active Ingredients

IngredientStrength
LOPERAMIDE HYDROCHLORIDE1 mg/7.5mL

OpenFDA Data

SPL SET ID:e09a277c-03b5-4d09-9058-a2d635e7d03c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1250685
    • UPC Code
  • 0036800367531

    • NDC Crossover Matching brand name "topcare loperamide hydrochloride" or generic name "Loperamide Hcl"

    NDCBrand NameGeneric Name
    36800-583topcare loperamide hydrochloridetopcare loperamide hydrochloride
    36800-645topcare loperamide hydrochloridetopcare loperamide hydrochloride
    10202-2247 Select Anti DiarrhealLoperamide HCl
    10202-6457 select anti diarrhealloperamide HCl
    0113-2224anti diarrhealLoperamide HCl
    0363-1010anti diarrhealLoperamide HCl
    0363-2022Anti Diarrhealloperamide HCl
    0363-0375Anti-DiarrhealLoperamide HCl
    11822-0375Anti-DiarrhealLoperamide HCl
    0498-1071Antidiarrheal ReliefLoperamide HCl
    0113-1645Good Sense antidiarrhealloperamide HCl
    0113-0645good sense loperamide hydrochlorideloperamide HCl
    0113-6004injoy diarrhea reliefLoperamide HCl
    0113-7224loperamide hydrochlorideLoperamide HCl
    0363-0645loperamide hydrochlorideloperamide HCl
    0363-1645loperamide hydrochlorideloperamide HCl
    0904-6256loperamide hydrochlorideloperamide HCl
    0904-6836loperamide hydrochlorideloperamide HCl
    11822-1645loperamide hydrochlorideloperamide HCl
    11822-5519loperamide hydrochlorideloperamide HCl
    11673-900Up and Up anti diarrhealloperamide HCl
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