NDC 68788-7235

Codeine-Guaifenesin

Codeine Phosphate And Guaifenesin

Codeine-Guaifenesin is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Preferred Pharmaceuticals Inc.. The primary component is Codeine Phosphate; Guaifenesin.

Product ID68788-7235_15b57703-639e-4b58-8a3c-3308b2cc9acb
NDC68788-7235
Product TypeHuman Otc Drug
Proprietary NameCodeine-Guaifenesin
Generic NameCodeine Phosphate And Guaifenesin
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2018-08-07
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NamePreferred Pharmaceuticals Inc.
Substance NameCODEINE PHOSPHATE; GUAIFENESIN
Active Ingredient Strength10 mg/5mL; mg/5mL
Pharm ClassesDecreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Full Opioid Agonists [MoA], Increased Respiratory Secretions [PE], Opioid Agonist [EPC]
DEA ScheduleCV
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68788-7235-1

120 mL in 1 BOTTLE (68788-7235-1)
Marketing Start Date2018-08-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-7235-1 [68788723501]

Codeine-Guaifenesin SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-08-07

Drug Details

Active Ingredients

IngredientStrength
CODEINE PHOSPHATE10 mg/5mL

OpenFDA Data

SPL SET ID:bce452df-8fd2-439e-a778-cd599afc9cd6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 995868
  • NDC Crossover Matching brand name "Codeine-Guaifenesin" or generic name "Codeine Phosphate And Guaifenesin"

    NDCBrand NameGeneric Name
    17856-0273Codeine-GuaifenesinCodeine Phosphate and Guaifenesin
    17856-0500Codeine-GuaifenesinCodeine Phosphate and Guaifenesin
    55700-741Codeine-GuaifenesinCodeine Phosphate and Guaifenesin
    58657-500Codeine-GuaifenesinCodeine Phosphate and Guaifenesin
    68071-2472Codeine-GuaifenesinCodeine Phosphate and Guaifenesin
    68071-5173Codeine-GuaifenesinCodeine Phosphate and Guaifenesin
    68788-7235Codeine-GuaifenesinCodeine Phosphate and Guaifenesin
    69367-272Codeine-GuaifenesinCodeine Phosphate and Guaifenesin
    0603-1075Cheratussin ACcodeine phosphate and guaifenesin
    21695-421Cheratussin ACcodeine phosphate and guaifenesin
    50090-0423Cheratussin ACcodeine phosphate and guaifenesin
    53002-3190Cheratussin ACcodeine phosphate and guaifenesin
    68788-9066Cheratussin ACcodeine phosphate and guaifenesin
    17856-0208Codeine Phosphate and Guaifenesincodeine phosphate and guaifenesin
    54932-208Codeine Phosphate and Guaifenesincodeine phosphate and guaifenesin
    57963-103G Tussin ACCODEINE PHOSPHATE and GUAIFENESIN
    0682-0475MAR-COF CGCODEINE PHOSPHATE and GUAIFENESIN
    58605-313Maxi-Tuss ACCODEINE PHOSPHATE and GUAIFENESIN
    50090-3170Virtussin A/CCodeine phosphate and Guaifenesin
    50436-2520Virtussin A/CCodeine phosphate and Guaifenesin
    50090-5398Virtussin ACCodeine phosphate and Guaifenesin
    63629-2486Virtussin ACCodeine phosphate and Guaifenesin
    63629-2487Virtussin ACCodeine phosphate and Guaifenesin
    69543-252Virtussin ACCodeine phosphate and Guaifenesin
    69543-251VIRTUSSIN AC W/ALCCodeine phosphate and guaifenesin

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