NDC 43378-126

Zodryl DEC 80

Codeine Phosphate, Guaifenesin And Pseudoephedrine Hydrochloride

Zodryl DEC 80 is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by Codadose, Inc.. The primary component is Pseudoephedrine; Codeine Phosphate; Guaifenesin.

Product ID43378-126_5e3f17d1-bcb6-4d05-bdd7-59012af8cf4b
NDC43378-126
Product TypeHuman Otc Drug
Proprietary NameZodryl DEC 80
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; CODEINE PHOSPHATE; GUAIFENESIN
Active Ingredient Strength30 mg/10mL; mg/10mL; mg/10mL
DEA ScheduleCV
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 43378-126-08

236 mL in 1 BOTTLE, PLASTIC (43378-126-08)
Marketing Start Date2009-08-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43378-126-08 [43378012608]

Zodryl DEC 80 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
PSEUDOEPHEDRINE30 mg/10mL

OpenFDA Data

SPL SET ID:20019e0e-7da5-4126-8595-06ec42ee8322
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1088951
  • 1088953
  • UPC Code
  • 0343378126089
  • NDC Crossover Matching brand name "Zodryl DEC 80" or generic name "Codeine Phosphate, Guaifenesin And Pseudoephedrine Hydrochloride"

    NDCBrand NameGeneric Name
    43378-126Zodryl DEC 80codeine 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
    43378-124Zodryl DEC 50codeine phosphate, guaifenesin and pseudoephedrine hydrochloride
    43378-125Zodryl DEC 60codeine phosphate, guaifenesin and pseudoephedrine hydrochloride

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