NDC 70147-414

Coditussin DAC

Codeine Phosphate, Guaifenesin, And Pseudoephedrine Hydrochloride

Coditussin DAC is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Glendale Inc. The primary component is Codeine Phosphate; Guaifenesin; Pseudoephedrine Hydrochloride.

Product ID70147-414_5a3c4507-724c-4145-8d32-be791e9c6fa4
NDC70147-414
Product TypeHuman Otc Drug
Proprietary NameCoditussin DAC
Generic NameCodeine Phosphate, Guaifenesin, And Pseudoephedrine Hydrochloride
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2016-05-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGlendale Inc
Substance NameCODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength10 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 70147-414-16

473 mL in 1 BOTTLE, PLASTIC (70147-414-16)
Marketing Start Date2016-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70147-414-16 [70147041416]

Coditussin DAC SYRUP
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2016-05-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CODEINE PHOSPHATE10 mg/5mL

OpenFDA Data

SPL SET ID:99f53fa4-98e0-4f0c-9bb2-4c7163f841ec
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1792707
  • NDC Crossover Matching brand name "Coditussin DAC" or generic name "Codeine Phosphate, Guaifenesin, And Pseudoephedrine Hydrochloride"

    NDCBrand NameGeneric Name
    70147-414Coditussin DACCODEINE PHOSPHATE, GUAIFENESIN, and PSEUDOEPHEDRINE HYDROCHLORIDE
    69543-253VIRTUSSIN DACcodeine phosphate, guaifenesin, and pseudoephedrine hydrochloride

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