NDC 0052-0108

REMERONSOLTAB

Mirtazapine

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

Product ID0052-0108_1594f744-89b7-488d-bf1b-516340e924f9
NDC0052-0108
Product TypeHuman Prescription Drug
Proprietary NameREMERONSOLTAB
Generic NameMirtazapine
Dosage FormTablet, Orally Disintegrating
Route of AdministrationORAL
Marketing Start Date2001-01-12
Marketing CategoryNDA / NDA
Application NumberNDA021208
Labeler NameOrganon USA Inc.
Substance NameMIRTAZAPINE
Active Ingredient Strength30 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0052-0108-30

5 BLISTER PACK in 1 BOX (0052-0108-30) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0052-0108-06)
Marketing Start Date2001-01-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0052-0108-06 [00052010806]

REMERONSOLTAB TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA021208
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-01-12

NDC 0052-0108-93 [00052010893]

REMERONSOLTAB TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA021208
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2001-01-12
Marketing End Date2011-08-17

NDC 0052-0108-30 [00052010830]

REMERONSOLTAB TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA021208
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-01-12

Drug Details

Active Ingredients

IngredientStrength
MIRTAZAPINE30 mg/1

OpenFDA Data

SPL SET ID:31f48378-27db-424f-a4c5-82584a553c35
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 752871
  • 752870
  • 283407
  • 283406
  • 752869
  • 283485
  • NDC Crossover Matching brand name "REMERONSOLTAB" or generic name "Mirtazapine"

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

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