NDC 50383-063

Guaifenesin

Guaifenesin

Guaifenesin is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Akorn. The primary component is Guaifenesin.

Product ID50383-063_2651ad0c-0f3f-44e2-8273-d480d6f50ecc
NDC50383-063
Product TypeHuman Otc Drug
Proprietary NameGuaifenesin
Generic NameGuaifenesin
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2012-03-07
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAkorn
Substance NameGUAIFENESIN
Active Ingredient Strength100 mg/5mL
Pharm ClassesDecreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50383-063-07

10 TRAY in 1 CASE (50383-063-07) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE
Marketing Start Date2012-03-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50383-063-10 [50383006310]

Guaifenesin SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2012-03-07

NDC 50383-063-17 [50383006317]

Guaifenesin SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2012-03-07

NDC 50383-063-07 [50383006307]

Guaifenesin SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2012-03-07

NDC 50383-063-12 [50383006312]

Guaifenesin SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2012-03-07

NDC 50383-063-11 [50383006311]

Guaifenesin SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2012-03-07

NDC 50383-063-15 [50383006315]

Guaifenesin SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2012-03-07

NDC 50383-063-18 [50383006318]

Guaifenesin SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2012-03-07

NDC 50383-063-05 [50383006305]

Guaifenesin SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2012-03-07

NDC 50383-063-06 [50383006306]

Guaifenesin SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2012-03-07

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN100 mg/5mL

OpenFDA Data

SPL SET ID:5cb704a7-301c-494e-948f-872ee0d5a289
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310604
  • UPC Code
  • 0350383063155
  • Medicade Reported Pricing

    50383063550 TRI-VITAMIN DROPS

    Pricing Unit: ML | Drug Type:

    50383063250 MULTIVITAMIN WITH IRON DROP

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "Guaifenesin" or generic name "Guaifenesin"

    NDCBrand NameGeneric Name
    0121-0744GUAIFENESINGUAIFENESIN
    0121-1488GUAIFENESINGUAIFENESIN
    0121-1744GUAIFENESINGUAIFENESIN
    0121-2232GUAIFENESINGUAIFENESIN
    0363-0028GuaifenesinGuaifenesin
    0363-0033GuaifenesinGuaifenesin
    70000-0106GuaifenesinGuaifenesin
    70518-1782GuaifenesinGuaifenesin
    0904-5154GuaifenesinGuaifenesin
    15338-769GuaifenesinGuaifenesin
    30142-703GuaifenesinGuaifenesin
    42291-313GuaifenesinGuaifenesin
    49349-511GuaifenesinGuaifenesin
    50383-063GuaifenesinGuaifenesin
    51660-070GUAIFENESINGUAIFENESIN
    55154-5780GUAIFENESINGUAIFENESIN
    55154-9437GuaifenesinGuaifenesin
    58657-509GuaifenesinGuaifenesin
    65162-037GuaifenesinGuaifenesin
    65162-036GuaifenesinGuaifenesin
    67046-251GuaifenesinGuaifenesin
    55154-9450GUAIFENESINGUAIFENESIN
    58602-810GuaifenesinGuaifenesin
    58602-811GuaifenesinGuaifenesin
    62207-569GUAIFENESINGUAIFENESIN
    79395-001GuaifenesinGuaifenesin
    69618-061GuaifenesinGuaifenesin
    58602-853GuaifenesinGuaifenesin
    63629-1156GuaifenesinGuaifenesin
    62207-839GUAIFENESINGUAIFENESIN
    62207-840GUAIFENESINGUAIFENESIN
    0363-0288childrens chest congestionGuaifenesin
    0113-0325Good Sense Mucus ERGuaifenesin
    0113-2023good sense mucus erguaifenesin
    0113-3650Good Sense Mucus ERGuaifenesin
    0113-0061good sense tussinGuaifenesin
    0363-0071MucusGuaifenesin
    0363-0074MucusGuaifenesin
    0363-0532Mucus ReliefGuaifenesin
    0363-0325mucus relief erGuaifenesin
    0031-9303Robitussin Direct Chest Congestionguaifenesin
    0031-8724Robitussin Mucus Plus Chest CongestionGuaifenesin
    0113-2061tussinGuaifenesin
    0363-0310wal tussinGuaifenesin

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.