NDC 52083-675

ABANATUSS PED

Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, Pseudoephedrine Hydrochloride

ABANATUSS PED is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Kramer Novis. The primary component is Chlophedianol Hydrochloride; Dexchlorpheniramine Maleate; Pseudoephedrine Hydrochloride.

Product ID52083-675_bb2fe455-c804-484e-93ba-2ae09e9ccbaf
NDC52083-675
Product TypeHuman Otc Drug
Proprietary NameABANATUSS PED
Generic NameChlophedianol Hydrochloride, Dexchlorpheniramine Maleate, Pseudoephedrine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2015-07-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameKRAMER NOVIS
Substance NameCHLOPHEDIANOL HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength25 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 52083-675-16

474 mL in 1 BOTTLE, PLASTIC (52083-675-16)
Marketing Start Date2015-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52083-675-16 [52083067516]

ABANATUSS PED SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2015-07-01

Drug Details

Active Ingredients

IngredientStrength
CHLOPHEDIANOL HYDROCHLORIDE25 mg/5mL

OpenFDA Data

SPL SET ID:99a38bc3-48ad-4d2a-9a10-3f7f57e5401d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1369972
  • NDC Crossover Matching brand name "ABANATUSS PED" or generic name "Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, Pseudoephedrine Hydrochloride"

    NDCBrand NameGeneric Name
    52083-675ABANATUSS PEDCHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE
    52083-685ABANATUSS PED DROPSCHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE

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