NDC 58552-317

GILTUSS TOTAL RELEASE

Guaifenesin, Dextromethorphan Hbr, And Phenylephrine Hcl

GILTUSS TOTAL RELEASE is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Gil Pharmaceutical Corp. The primary component is Guaifenesin; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID58552-317_79253d6f-dd40-5761-e053-2a91aa0af69e
NDC58552-317
Product TypeHuman Otc Drug
Proprietary NameGILTUSS TOTAL RELEASE
Generic NameGuaifenesin, Dextromethorphan Hbr, And Phenylephrine Hcl
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2009-10-19
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGil Pharmaceutical Corp
Substance NameGUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength388 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 58552-317-02

12 BLISTER PACK in 1 CARTON (58552-317-02) > 2 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2011-07-15
NDC Exclude FlagN
Sample Package?Y

NDC SPL Data Element Entries

NDC 58552-317-02 [58552031702]

GILTUSS TOTAL RELEASE TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-07-15

NDC 58552-317-01 [58552031701]

GILTUSS TOTAL RELEASE TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2011-05-27
Marketing End Date2020-11-30

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN388 mg/1

OpenFDA Data

SPL SET ID:a854de22-2f90-48c9-8cde-98446f7958b9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 899263
  • NDC Crossover Matching brand name "GILTUSS TOTAL RELEASE" or generic name "Guaifenesin, Dextromethorphan Hbr, And Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    58552-317GILTUSS TOTAL RELEASEGuaifenesin, Dextromethorphan HBr, and Phenylephrine HCl
    58552-327EXACTUSS TOTAL RELEASEGuaifenesin, Dextromethorphan HBr, and Phenylephrine HCl

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