NDC 0052-4365

REMERON

Mirtazapine

REMERON is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Organon Usa Inc.. The primary component is Mirtazapine.

Product ID0052-4365_1594f744-89b7-488d-bf1b-516340e924f9
NDC0052-4365
Product TypeHuman Prescription Drug
Proprietary NameREMERON
Generic NameMirtazapine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-05-17
Marketing CategoryNDA / NDA
Application NumberNDA020415
Labeler NameOrganon USA Inc.
Substance NameMIRTAZAPINE
Active Ingredient Strength30 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0052-4365-01

1 BOTTLE in 1 CARTON (0052-4365-01) > 30 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2018-05-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0052-4365-01 [00052436501]

REMERON TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020415
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-17

Drug Details

Active Ingredients

IngredientStrength
MIRTAZAPINE30 mg/1

OpenFDA Data

SPL SET ID:010f9162-9f7f-4b6d-a6e4-4f832f26f38e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 261135
  • 311725
  • 311726
  • 211323
  • 211322
  • 314111
  • NDC Crossover Matching brand name "REMERON" or generic name "Mirtazapine"

    NDCBrand NameGeneric Name
    0052-0105REMERONMIRTAZAPINE
    0052-0107REMERONMIRTAZAPINE
    0052-0109REMERONMIRTAZAPINE
    0052-4364REMERONMIRTAZAPINE
    0052-4365REMERONMIRTAZAPINE
    70518-0903REMERONREMERON
    70518-2176REMERONREMERON
    0093-7206MirtazapineMirtazapine
    0093-7207MirtazapineMirtazapine
    0093-7208MirtazapineMirtazapine
    0115-1653MirtazapineMirtazapine
    0115-1654MirtazapineMirtazapine
    0115-1656MirtazapineMirtazapine
    0185-0020mirtazapinemirtazapine
    0052-0106REMERONSOLTABMIRTAZAPINE
    0052-0108REMERONSOLTABMIRTAZAPINE
    0052-0110REMERONSOLTABMIRTAZAPINE

    Trademark Results [REMERON]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    REMERON
    REMERON
    74552154 2061796 Live/Registered
    MERCK SHARP & DOHME B.V.
    1994-07-21

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