NDC 0904-6479

Robafen AC

Guaifenesin And Codeine Phosphate

Robafen AC is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Guaifenesin; Codeine Phosphate.

Product ID0904-6479_7f71d878-e663-288b-e053-2a91aa0a750a
NDC0904-6479
Product TypeHuman Otc Drug
Proprietary NameRobafen AC
Generic NameGuaifenesin And Codeine Phosphate
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2017-12-14
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameMajor Pharmaceuticals
Substance NameGUAIFENESIN; CODEINE PHOSPHATE
Active Ingredient Strength100 mg/5mL; mg/5mL
DEA ScheduleCV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0904-6479-16

473 mL in 1 BOTTLE (0904-6479-16)
Marketing Start Date2017-12-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6479-16 [00904647916]

Robafen AC SYRUP
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2017-12-14
Marketing End Date2020-10-31

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN100 mg/5mL

OpenFDA Data

SPL SET ID:e910cc7a-574a-4b3a-b32a-4ba077312873
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 995868
  • 996484
    • UPC Code
  • 0309046479161

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

    NDCBrand NameGeneric Name
    0904-6479Robafen ACGuaifenesin 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
    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
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