NDC 0113-2008

sinus congestion

Pseudoephedrine Hcl

sinus congestion is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by L. Perrigo Company. The primary component is Pseudoephedrine Hydrochloride.

Product ID0113-2008_84ba172c-07a9-4153-8e4a-c2027bda8dc9
NDC0113-2008
Product TypeHuman Otc Drug
Proprietary Namesinus congestion
Generic NamePseudoephedrine Hcl
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-10-04
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameL. Perrigo Company
Substance NamePSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength30 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0113-2008-62

12 BLISTER PACK in 1 CARTON (0113-2008-62) > 2 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2016-10-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0113-2008-62 [00113200862]

sinus congestion TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-04

NDC 0113-2008-80 [00113200880]

sinus congestion TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-04

NDC 0113-2008-67 [00113200867]

sinus congestion TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-04

Drug Details

Active Ingredients

IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/1

OpenFDA Data

SPL SET ID:2dd0e007-4aeb-4b51-815e-4ebe378a4095
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049160
  • NDC Crossover Matching brand name "sinus congestion" or generic name "Pseudoephedrine Hcl"

    NDCBrand NameGeneric Name
    0113-2008sinus congestionPseudoephedrine HCl
    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
    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

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