NDC 48964-112

Nexafed

Pseudoephedrine Hcl

Nexafed is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Acura Pharmaceuticals, Inc.. The primary component is Pseudoephedrine Hydrochloride.

Product ID48964-112_a975d616-39ee-6a7c-e053-2995a90ad3bc
NDC48964-112
Product TypeHuman Otc Drug
Proprietary NameNexafed
Generic NamePseudoephedrine Hcl
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-07-10
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAcura Pharmaceuticals, Inc.
Substance NamePSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength30 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 48964-112-24

2 BLISTER PACK in 1 CARTON (48964-112-24) > 12 TABLET in 1 BLISTER PACK
Marketing Start Date2020-07-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 48964-112-24 [48964011224]

nexafed TABLET
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2012-12-10
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/1

OpenFDA Data

SPL SET ID:0881e041-ef70-4aa6-884d-1044cf86c2a2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049160
  • 1361515

    • NDC Crossover Matching brand name "Nexafed" or generic name "Pseudoephedrine Hcl"

    NDCBrand NameGeneric Name
    48964-112nexafednexafed
    0113-0432Good Sense Nasal DecongestantPseudoephedrine HCl
    0113-2432Nasal DecongestantPseudoephedrine HCl
    0363-1214Nasal DecongestantPseudoephedrine HCl
    0536-3607Nasal DecongestantPseudoephedrine HCl
    0536-4391Nasal DecongestantPseudoephedrine HCl
    21130-112Nasal DecongestantPseudoephedrine HCl
    0904-6990Pseudoephedrine HClPseudoephedrine HCl
    0113-2017sinus 12 hourPseudoephedrine HCl
    0113-2008sinus congestionPseudoephedrine HCl
    11822-0112Sinus Pressure and Congestion ReliefPseudoephedrine HCl
    11822-0650sinus pressure and congestion reliefPseudoephedrine HCl
    0904-5053SudoGestPseudoephedrine HCl
    0904-6338SudoGestPSEUDOEPHEDRINE HCL
    0904-6754SudoGest 12 HourPseudoephedrine HCl
    0904-6337SudoGest Nasal DecongestantPseudoephedrine HCl
    11673-112up and up sinus 12 hourPseudoephedrine HCl
    0363-0112Wal-phedPseudoephedrine HCl
    0363-0061walphed dPseudoephedrine HCl

    Trademark Results [Nexafed]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NEXAFED
    NEXAFED
    85221351 4151083 Live/Registered
    Acura Pharmaceuticals, Inc.
    2011-01-19
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