NDC 50580-317

Imodium A-D

Loperamide Hydrochloride

Imodium A-D is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Loperamide Hydrochloride.

Product ID50580-317_4a17e6a4-059a-48b0-b716-c9683f4867ab
NDC50580-317
Product TypeHuman Otc Drug
Proprietary NameImodium A-D
Generic NameLoperamide Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-07-13
Marketing CategoryANDA / ANDA
Application NumberANDA075232
Labeler NameJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Substance NameLOPERAMIDE HYDROCHLORIDE
Active Ingredient Strength2 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50580-317-01

1 BLISTER PACK in 1 CARTON (50580-317-01) > 6 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2015-07-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-317-04 [50580031704]

Imodium A-D TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075232
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-07-13
Marketing End Date2018-12-31

NDC 50580-317-05 [50580031705]

Imodium A-D TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075232
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2015-07-13

NDC 50580-317-06 [50580031706]

Imodium A-D TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075232
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2020-02-10

NDC 50580-317-01 [50580031701]

Imodium A-D TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075232
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-07-13

NDC 50580-317-03 [50580031703]

Imodium A-D TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075232
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2015-07-13

Drug Details

Active Ingredients

IngredientStrength
LOPERAMIDE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:01da76d0-1979-4c45-9d39-c72ae4e4ffe2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 978010
  • 978013
  • NDC Crossover Matching brand name "Imodium A-D" or generic name "Loperamide Hydrochloride"

    NDCBrand NameGeneric Name
    50580-317Imodium A-DImodium A-D
    50580-134Imodium A-DImodium A-D
    50580-367Imodium A-DImodium A-D
    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

    Trademark Results [Imodium]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    IMODIUM
    IMODIUM
    73017758 1005190 Live/Registered
    JANSSEN PHARMACEUTICA N.V.
    1974-04-02

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