NDC 41520-429

CareOne Nasal and Sinus Decongestant

Pseudoephedrine Hcl

CareOne Nasal and Sinus Decongestant is a Oral Tablet, Film Coated, Extended Release in the Human Otc Drug category. It is labeled and distributed by American Sales Company. The primary component is Pseudoephedrine Hydrochloride.

Product ID41520-429_4d029cac-77b4-42b8-ab8e-d352c5293d31
NDC41520-429
Product TypeHuman Otc Drug
Proprietary NameCareOne Nasal and Sinus Decongestant
Generic NamePseudoephedrine Hcl
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-09-15
Marketing CategoryANDA / ANDA
Application NumberANDA075153
Labeler NameAmerican Sales Company
Substance NamePSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength120 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 41520-429-52

10 BLISTER PACK in 1 CARTON (41520-429-52) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2016-09-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 41520-429-60 [41520042960]

CareOne Nasal and Sinus Decongestant TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075153
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-09-15

NDC 41520-429-52 [41520042952]

CareOne Nasal and Sinus Decongestant TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA075153
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-09-15

Drug Details

Active Ingredients

IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE120 mg/1

OpenFDA Data

SPL SET ID:a5aa414c-a143-44c8-9759-e84c0f032fbf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049154

    • NDC Crossover Matching brand name "CareOne Nasal and Sinus Decongestant" or generic name "Pseudoephedrine Hcl"

    NDCBrand NameGeneric Name
    41520-429CareOne Nasal and Sinus DecongestantCareOne Nasal and Sinus Decongestant
    41520-881CareOne Nasal and Sinus DecongestantCareOne Nasal and Sinus Decongestant
    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
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