NDC 70518-1618

pseudoephedrine hydrochloride

Pseudoephedrine Hcl

pseudoephedrine hydrochloride is a Oral Tablet, Film Coated, Extended Release in the Human Otc Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Pseudoephedrine Hydrochloride.

Product ID70518-1618_798d3ae3-fd3a-23b3-e053-2a91aa0a745d
NDC70518-1618
Product TypeHuman Otc Drug
Proprietary Namepseudoephedrine hydrochloride
Generic NamePseudoephedrine Hcl
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-10-30
Marketing CategoryANDA / ANDA
Application NumberANDA075153
Labeler NameREMEDYREPACK INC.
Substance NamePSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength120 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-1618-0

1 BLISTER PACK in 1 CARTON (70518-1618-0) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2018-10-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1618-0 [70518161800]

pseudoephedrine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075153
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-10-30

Drug Details

Active Ingredients

IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE120 mg/1

OpenFDA Data

SPL SET ID:ed560e21-20ca-42d6-a745-b1551aabe957
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049154

    • NDC Crossover Matching brand name "pseudoephedrine hydrochloride" or generic name "Pseudoephedrine Hcl"

    NDCBrand NameGeneric Name
    0363-0204Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    0904-6727Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    68016-204Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    69842-204Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    70000-0164Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    70518-1618pseudoephedrine hydrochloridepseudoephedrine hydrochloride
    71205-197pseudoephedrine hydrochloridepseudoephedrine hydrochloride
    0904-6728Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    21130-204Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    37808-204Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    37012-204Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    41250-204Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    45802-432pseudoephedrine hydrochloridepseudoephedrine hydrochloride
    45802-107pseudoephedrine hydrochloridepseudoephedrine hydrochloride
    46122-166Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    51660-204Pseudoephedrine hydrochloridePseudoephedrine hydrochloride
    51660-492Pseudoephedrine hydrochloridePseudoephedrine hydrochloride
    53943-204Pseudoephedrine hydrochloridePseudoephedrine hydrochloride
    56062-204Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    57344-035Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    59779-204Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    62011-0306Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    63868-143Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    68196-204Pseudoephedrine hydrochloridePseudoephedrine hydrochloride
    0904-6907Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    37808-007Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    50090-4546Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    70518-2318Pseudoephedrine HydrochloridePseudoephedrine Hydrochloride
    0113-205412 hour decongestantPseudoephedrine Hydrochloride
    0113-0432Good Sense Nasal DecongestantPseudoephedrine HCl
    0113-0054Good Sense SuphedrinePseudoephedrine Hydrochloride
    0113-2432Nasal DecongestantPseudoephedrine HCl
    0363-1214Nasal DecongestantPseudoephedrine HCl
    0536-3607Nasal DecongestantPseudoephedrine HCl
    0536-4391Nasal DecongestantPseudoephedrine HCl
    0363-3301Nasal Decongestant DPseudoephedrine Hydrochloride
    0536-1850RugbyPseudoephedrine Hydrochloride
    0113-2017sinus 12 hourPseudoephedrine HCl
    0113-2008sinus congestionPseudoephedrine HCl
    0904-5053SudoGestPseudoephedrine HCl
    0904-5125SudoGestPseudoephedrine Hydrochloride
    0904-5803SudoGestPseudoephedrine Hydrochloride
    0904-6338SudoGestPSEUDOEPHEDRINE HCL
    0904-6337SudoGest Nasal DecongestantPseudoephedrine HCl
    0363-0112Wal-phedPseudoephedrine HCl
    0363-0061walphed dPseudoephedrine HCl
    0113-0401Zephrex Dpseudoephedrine hydrochloride
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