NDC 10135-682

Guaifenesin 400mg

Guaifenesin

Guaifenesin 400mg is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Marlex Pharmaceuticals Inc. The primary component is Guaifenesin.

Product ID10135-682_068f3a4b-b5dd-4904-8c72-3d650af5f0c5
NDC10135-682
Product TypeHuman Otc Drug
Proprietary NameGuaifenesin 400mg
Generic NameGuaifenesin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-03-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameMarlex Pharmaceuticals Inc
Substance NameGUAIFENESIN
Active Ingredient Strength400 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 10135-682-30

30 TABLET in 1 BOTTLE (10135-682-30)
Marketing Start Date2019-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10135-682-60 [10135068260]

Guaifenesin 400mg TABLET
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2019-03-01

NDC 10135-682-30 [10135068230]

Guaifenesin 400mg TABLET
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2019-03-01

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN400 mg/1

OpenFDA Data

SPL SET ID:43ca292e-3128-47fc-9f20-b7e8c8677d4d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 359601

    • NDC Crossover Matching brand name "Guaifenesin 400mg" or generic name "Guaifenesin"

    NDCBrand NameGeneric Name
    10135-682Guaifenesin 400mgGuaifenesin 400mg
    53329-987Guaifenesin 400mgGuaifenesin 400mg
    0363-0288childrens chest congestionGuaifenesin
    0113-0325Good Sense Mucus ERGuaifenesin
    0113-2023good sense mucus erguaifenesin
    0113-3650Good Sense Mucus ERGuaifenesin
    0113-0061good sense tussinGuaifenesin
    0121-0744GUAIFENESINGUAIFENESIN
    0121-1488GUAIFENESINGUAIFENESIN
    0121-1744GUAIFENESINGUAIFENESIN
    0121-2232GUAIFENESINGUAIFENESIN
    0363-0028GuaifenesinGuaifenesin
    0363-0033GuaifenesinGuaifenesin
    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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