NDC 66594-499

PRO-RED AC

Codeine Phosphate, Dexchorpheniramine Maleate, Phenylephrine Hydrochloride

PRO-RED AC is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Pro-pharma, Llc. The primary component is Codeine Phosphate; Dexchlorpheniramine Maleate; Phenylephrine Hydrochloride.

Product ID66594-499_cc958709-6208-4ae0-8d57-2361bf78d826
NDC66594-499
Product TypeHuman Otc Drug
Proprietary NamePRO-RED AC
Generic NameCodeine Phosphate, Dexchorpheniramine Maleate, Phenylephrine Hydrochloride
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2013-09-30
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NamePro-Pharma, LLC
Substance NameCODEINE PHOSPHATE; DEXCHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength9 mg/5mL; mg/5mL; mg/5mL
DEA ScheduleCV
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 66594-499-16

473 mL in 1 BOTTLE (66594-499-16)
Marketing Start Date2013-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66594-499-01 [66594049901]

PRO-RED AC SYRUP
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-09-30
Inactivation Date2019-11-27

NDC 66594-499-16 [66594049916]

PRO-RED AC SYRUP
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2013-09-30
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
CODEINE PHOSPHATE9 mg/5mL

OpenFDA Data

SPL SET ID:72355a55-e1b9-4004-9d2d-e215f947946e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1440003
  • Medicade Reported Pricing

    66594049916 PRO-RED AC SYRUP

    Pricing Unit: ML | Drug Type:

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