NDC 41520-645

CareOne loperamide hydrochloride

Loperamide Hcl

CareOne loperamide hydrochloride is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by American Sales Company. The primary component is Loperamide Hydrochloride.

Product ID41520-645_20a962f9-f6a2-4d9a-ad65-d0eeba10bce6
NDC41520-645
Product TypeHuman Otc Drug
Proprietary NameCareOne loperamide hydrochloride
Generic NameLoperamide Hcl
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2012-05-21
Marketing CategoryANDA / ANDA
Application NumberANDA091292
Labeler NameAmerican Sales Company
Substance NameLOPERAMIDE HYDROCHLORIDE
Active Ingredient Strength1 mg/7.5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 41520-645-34

240 mL in 1 BOTTLE (41520-645-34)
Marketing Start Date2014-10-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 41520-645-26 [41520064526]

CareOne loperamide hydrochloride SUSPENSION
Marketing CategoryANDA
Application NumberANDA091292
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-05-21

NDC 41520-645-34 [41520064534]

CareOne loperamide hydrochloride SUSPENSION
Marketing CategoryANDA
Application NumberANDA091292
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-10-13

Drug Details

Active Ingredients

IngredientStrength
LOPERAMIDE HYDROCHLORIDE1 mg/7.5mL

OpenFDA Data

SPL SET ID:261d89d1-37cb-4af9-ad82-7e79f8da2e7f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1250685
    • UPC Code
  • 0341520000010

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

    NDCBrand NameGeneric Name
    41520-645CareOne loperamide hydrochlorideCareOne 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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