NDC 11534-164

Guiafenesin

Guiafenesin

Guiafenesin is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Sunrise Pharmaceutical Inc. The primary component is Guaifenesin.

Product ID11534-164_252a4044-8b7f-4d7f-b501-3d089ca4bb5a
NDC11534-164
Product TypeHuman Otc Drug
Proprietary NameGuiafenesin
Generic NameGuiafenesin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2005-07-08
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameSunrise Pharmaceutical Inc
Substance NameGUAIFENESIN
Active Ingredient Strength400 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 11534-164-01

100 TABLET in 1 BOTTLE (11534-164-01)
Marketing Start Date2005-07-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11534-164-01 [11534016401]

Guiafenesin TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2005-07-08
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN400 mg/1

OpenFDA Data

SPL SET ID:5e3875ba-d34c-48b2-93ec-baa27f6a37a2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 359601

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