NDC 15370-150

RYCLORA

Dexchlorpheniramine Maleate

RYCLORA is a Oral Liquid in the Human Prescription Drug category. It is labeled and distributed by Carwin Pharmaceutical Associates, Llc. The primary component is Dexchlorpheniramine Maleate.

Product ID15370-150_0925bee7-88bd-4092-abc0-c7de3f21c9a4
NDC15370-150
Product TypeHuman Prescription Drug
Proprietary NameRYCLORA
Generic NameDexchlorpheniramine Maleate
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2018-10-07
Marketing CategoryANDA / ANDA
Application NumberANDA202520
Labeler NameCARWIN PHARMACEUTICAL ASSOCIATES, LLC
Substance NameDEXCHLORPHENIRAMINE MALEATE
Active Ingredient Strength2 mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 15370-150-04

118 mL in 1 BOTTLE, PLASTIC (15370-150-04)
Marketing Start Date2018-10-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 15370-150-04 [15370015004]

RYCLORA LIQUID
Marketing CategoryANDA
Application NumberANDA202520
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-10-07

NDC 15370-150-16 [15370015016]

RYCLORA LIQUID
Marketing CategoryANDA
Application NumberANDA202520
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-07

NDC 15370-150-99 [15370015099]

RYCLORA LIQUID
Marketing CategoryANDA
Application NumberANDA202520
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-07

Drug Details

Active Ingredients

IngredientStrength
DEXCHLORPHENIRAMINE MALEATE2 mg/5mL

OpenFDA Data

SPL SET ID:aa4f80c9-e600-4bc0-8528-02a8162a36f0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 702220
  • 2058856
    • UPC Code
  • 0315370150164

    • NDC Crossover Matching brand name "RYCLORA" or generic name "Dexchlorpheniramine Maleate"

    NDCBrand NameGeneric Name
    15370-150RYCLORADexchlorpheniramine Maleate
    69067-102Dexchlorpheniramine MaleateDexchlorpheniramine Maleate
    64543-600POLMONDexchlorpheniramine Maleate

    Trademark Results [RYCLORA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    RYCLORA
    RYCLORA
    87782094 not registered Live/Pending
    Carwin Pharmaceutical Associates, LLC
    2018-02-02
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