NDC 43378-106

Zodryl AC 80

Chlorpheniramine Maleate And Codeine Phosphate

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

Product ID43378-106_1600c314-ebc0-4ac3-9d8b-bc4d5073857b
NDC43378-106
Product TypeHuman Otc Drug
Proprietary NameZodryl AC 80
Generic NameChlorpheniramine Maleate And Codeine Phosphate
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2009-08-24
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameCodaDose, Inc.
Substance NameCHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE
Active Ingredient Strength2 mg/10mL; mg/10mL
DEA ScheduleCV
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 43378-106-08

236 mL in 1 BOTTLE, PLASTIC (43378-106-08)
Marketing Start Date2009-08-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43378-106-08 [43378010608]

Zodryl AC 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
CHLORPHENIRAMINE MALEATE2 mg/10mL

OpenFDA Data

SPL SET ID:c42efb6c-ecf7-4802-aef4-f901b3bd6dca
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 995062
  • 995064
  • NDC Crossover Matching brand name "Zodryl AC 80" or generic name "Chlorpheniramine Maleate And Codeine Phosphate"

    NDCBrand NameGeneric Name
    43378-106Zodryl AC 80Chlorpheniramine Maleate and Codeine Phosphate
    43378-104Zodryl AC 50Chlorpheniramine Maleate and Codeine Phosphate
    43378-105Zodryl AC 60Chlorpheniramine Maleate and Codeine Phosphate

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.