NDC 43378-124

Zodryl DEC 50

Codeine Phosphate, Guaifenesin And Pseudoephedrine Hydrochloride

Zodryl DEC 50 is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by Codadose, Inc.. The primary component is Pseudoephedrine Hydrochloride; Codeine Phosphate; Guaifenesin.

Product ID43378-124_5ace705f-df68-4517-b65a-06c468111906
NDC43378-124
Product TypeHuman Otc Drug
Proprietary NameZodryl DEC 50
Generic NameCodeine Phosphate, Guaifenesin And Pseudoephedrine Hydrochloride
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2009-08-24
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameCodaDose, Inc.
Substance NamePSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE; GUAIFENESIN
Active Ingredient Strength30 mg/5mL; mg/5mL; mg/5mL
DEA ScheduleCV
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 43378-124-08

236 mL in 1 BOTTLE, PLASTIC (43378-124-08)
Marketing Start Date2009-08-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43378-124-08 [43378012408]

Zodryl DEC 50 SUSPENSION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2009-08-24
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/5mL

OpenFDA Data

SPL SET ID:2abe5326-bf61-410f-84ea-89a39bd954d0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1089030
  • 1089028
  • NDC Crossover Matching brand name "Zodryl DEC 50" or generic name "Codeine Phosphate, Guaifenesin And Pseudoephedrine Hydrochloride"

    NDCBrand NameGeneric Name
    43378-124Zodryl DEC 50codeine phosphate, guaifenesin and pseudoephedrine hydrochloride
    43378-120Zodryl DEC 25codeine phosphate, guaifenesin and pseudoephedrine hydrochloride
    43378-121Zodryl DEC 30codeine phosphate, guaifenesin and pseudoephedrine hydrochloride
    43378-123Zodryl DEC 40codeine phosphate, guaifenesin and pseudoephedrine hydrochloride
    43378-125Zodryl DEC 60codeine phosphate, guaifenesin and pseudoephedrine hydrochloride
    43378-126Zodryl DEC 80codeine phosphate, guaifenesin and pseudoephedrine hydrochloride

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