NDC 65162-037

Guaifenesin

Guaifenesin

Guaifenesin is a Oral Tablet, Extended Release in the Human Otc Drug category. It is labeled and distributed by Amneal Pharmaceuticals Llc. The primary component is Guaifenesin.

Product ID65162-037_86a7b28a-da75-460d-b7e6-37696207155f
NDC65162-037
Product TypeHuman Otc Drug
Proprietary NameGuaifenesin
Generic NameGuaifenesin
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-07-27
Marketing CategoryANDA / ANDA
Application NumberANDA207342
Labeler NameAmneal Pharmaceuticals LLC
Substance NameGUAIFENESIN
Active Ingredient Strength1200 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 65162-037-03

1 BOTTLE in 1 CARTON (65162-037-03) > 30 TABLET, EXTENDED RELEASE in 1 BOTTLE
Marketing Start Date2018-07-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65162-037-06 [65162003706]

Guaifenesin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207342
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-07-27

NDC 65162-037-03 [65162003703]

Guaifenesin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207342
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-07-27

NDC 65162-037-28 [65162003728]

Guaifenesin TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207342
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-07-27

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN1200 mg/1

OpenFDA Data

SPL SET ID:ad67e6fd-a68f-44db-9718-84a2cef86e09
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 636522
  • 310621
    • UPC Code
  • 0365162037289
  • 0365162036060
  • 0365162037067
  • 0365162036022
  • 0365162037036
  • 0365162036039

    • Medicade Reported Pricing

    65162037310 OXYBUTYNIN CL ER 15 MG TABLET

    Pricing Unit: EA | Drug Type:

    65162037250 OXYBUTYNIN CL ER 10 MG TABLET

    Pricing Unit: EA | Drug Type:

    65162037210 OXYBUTYNIN CL ER 10 MG TABLET

    Pricing Unit: EA | Drug Type:

    65162037150 OXYBUTYNIN CL ER 5 MG TABLET

    Pricing Unit: EA | Drug Type:

    65162037110 OXYBUTYNIN CL ER 5 MG TABLET

    Pricing Unit: EA | 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
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