NDC 58602-804

Pseudoephedrine HCl

Pseudoephedrine Hcl

Pseudoephedrine HCl is a Oral Tablet, Extended Release in the Human Otc Drug category. It is labeled and distributed by Aurohealth Llc. The primary component is Pseudoephedrine Hydrochloride.

Product ID58602-804_1056d9da-8a3f-4b7a-878e-7f8d45d298cd
NDC58602-804
Product TypeHuman Otc Drug
Proprietary NamePseudoephedrine HCl
Generic NamePseudoephedrine Hcl
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-06-09
Marketing CategoryANDA / ANDA
Application NumberANDA209008
Labeler NameAurohealth LLC
Substance NamePSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength120 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 58602-804-67

2 BLISTER PACK in 1 CARTON (58602-804-67) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2017-06-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58602-804-67 [58602080467]

Pseudoephedrine HCl TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209008
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-06-09

NDC 58602-804-83 [58602080483]

Pseudoephedrine HCl TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209008
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-06-09

Drug Details

Active Ingredients

IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE120 mg/1

OpenFDA Data

SPL SET ID:1056d9da-8a3f-4b7a-878e-7f8d45d298cd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049154

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

    NDCBrand NameGeneric Name
    0904-6990Pseudoephedrine HClPseudoephedrine HCl
    50844-211Pseudoephedrine HClPseudoephedrine HCl
    58602-804Pseudoephedrine HClPseudoephedrine 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
    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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