NDC 12634-969

Guaifenesin and Codeine Phosphate

Guaifenesin And Codeine Phosphate

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

Product ID12634-969_5a66f7eb-5670-4ee1-b48f-0d0a11b554c6
NDC12634-969
Product TypeHuman Otc Drug
Proprietary NameGuaifenesin and Codeine Phosphate
Generic NameGuaifenesin And Codeine Phosphate
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2011-01-28
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameApotheca, Inc
Substance NameGUAIFENESIN; CODEINE PHOSPHATE
Active Ingredient Strength100 mg/5mL; mg/5mL
DEA ScheduleCV
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 12634-969-04

120 mL in 1 BOTTLE (12634-969-04)
Marketing Start Date2011-01-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12634-969-04 [12634096904]

Guaifenesin and Codeine Phosphate SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-01-28
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN100 mg/5mL

OpenFDA Data

SPL SET ID:efe0117a-0afe-4d79-a01f-742395613081
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 995868

    • NDC Crossover Matching brand name "Guaifenesin and Codeine Phosphate" or generic name "Guaifenesin And Codeine Phosphate"

    NDCBrand NameGeneric Name
    0121-0775Guaifenesin and Codeine PhosphateGuaifenesin and Codeine Phosphate
    0121-1550Guaifenesin and Codeine PhosphateGuaifenesin and Codeine Phosphate
    0121-1775Guaifenesin and Codeine PhosphateGuaifenesin and Codeine Phosphate
    12634-969Guaifenesin and Codeine PhosphateGuaifenesin and Codeine Phosphate
    49999-610Guaifenesin and Codeine PhosphateGuaifenesin and Codeine Phosphate
    50090-1428Guaifenesin and Codeine PhosphateGuaifenesin and Codeine Phosphate
    53002-3191Guaifenesin and Codeine PhosphateGuaifenesin and Codeine Phosphate
    61919-110GUAIFENESIN AND CODEINE PHOSPHATEGUAIFENESIN AND CODEINE PHOSPHATE
    63187-117Guaifenesin and Codeine PhosphateGuaifenesin and Codeine Phosphate
    68071-1350Guaifenesin and Codeine PhosphateGuaifenesin and Codeine Phosphate
    68258-8904Guaifenesin and Codeine PhosphateGuaifenesin and Codeine Phosphate
    68788-7608Guaifenesin and Codeine PhosphateGuaifenesin and Codeine Phosphate
    70518-2434Guaifenesin and Codeine PhosphateGuaifenesin and Codeine Phosphate
    70752-177GUAIFENESIN and CODEINE PHOSPHATEGUAIFENESIN and CODEINE PHOSPHATE
    70752-180GUAIFENESIN and CODEINE PHOSPHATEGUAIFENESIN and CODEINE PHOSPHATE
    50090-2651Guaiatussin ACguaifenesin and codeine phosphate
    50383-087Guaiatussin ACguaifenesin and codeine phosphate
    68788-7550Guaiatussin ACguaifenesin and codeine phosphate
    16571-302Guaifenesin ACGuaifenesin and Codeine Phosphate
    0904-6479Robafen ACGuaifenesin and Codeine Phosphate
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