NDC 0115-1656

Mirtazapine

Mirtazapine

Mirtazapine is a Oral Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Of New York Llc. The primary component is Mirtazapine.

Product ID0115-1656_0711798d-694c-41d0-b7d6-40b1a1930c87
NDC0115-1656
Product TypeHuman Prescription Drug
Proprietary NameMirtazapine
Generic NameMirtazapine
Dosage FormTablet, Orally Disintegrating
Route of AdministrationORAL
Marketing Start Date2016-11-01
Marketing End Date2019-12-31
Marketing CategoryANDA / ANDA
Application NumberANDA076307
Labeler NameAmneal Pharmaceuticals of New York LLC
Substance NameMIRTAZAPINE
Active Ingredient Strength45 mg/1
NDC Exclude FlagN

Packaging

NDC 0115-1656-08

30 BLISTER PACK in 1 CARTON (0115-1656-08) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Start Date2016-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0115-1656-08 [00115165608]

Mirtazapine TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA076307
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-01
Marketing End Date2019-12-31

Drug Details

Active Ingredients

IngredientStrength
MIRTAZAPINE45 mg/1

OpenFDA Data

SPL SET ID:2f9b75a4-193e-4c0f-a5f8-15576f4690f1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 283485
  • 283407
  • 283406
  • NDC Crossover Matching brand name "Mirtazapine" or generic name "Mirtazapine"

    NDCBrand NameGeneric Name
    0093-7206MirtazapineMirtazapine
    0093-7207MirtazapineMirtazapine
    0093-7208MirtazapineMirtazapine
    0115-1653MirtazapineMirtazapine
    0115-1654MirtazapineMirtazapine
    0115-1656MirtazapineMirtazapine
    0185-0020mirtazapinemirtazapine
    68071-1716MirtazapineMirtazapine
    68071-1659MirtazapineMirtazapine
    68071-4045MirtazapineMirtazapine
    68071-4003MirtazapineMirtazapine
    68071-4295MirtazapineMirtazapine
    68071-4239MirtazapineMirtazapine
    68071-4379MirtazapineMirtazapine
    68071-4752MirtazapineMirtazapine
    68071-4539MirtazapineMirtazapine
    68084-121MirtazapineMirtazapine
    68084-120MirtazapineMirtazapine
    68084-119MirtazapineMirtazapine
    68382-679mirtazapinemirtazapine
    68382-676mirtazapinemirtazapine
    68382-677mirtazapinemirtazapine
    68788-7196MirtazapineMirtazapine
    68788-7172MirtazapineMirtazapine
    68788-7251MirtazapineMirtazapine
    68788-9981MirtazapineMirtazapine
    0591-1117MirtazapineMirtazapine
    0591-1118MirtazapineMirtazapine
    70518-0101MirtazapineMirtazapine
    70518-0180MirtazapineMirtazapine
    0591-1119MirtazapineMirtazapine
    0591-2470MirtazapineMirtazapine
    70518-0316MirtazapineMirtazapine
    70518-0102MirtazapineMirtazapine
    70518-0276MirtazapineMirtazapine
    70518-0901MirtazapineMirtazapine
    70518-0977MirtazapineMirtazapine
    70518-1397MirtazapineMirtazapine
    70518-1352MirtazapineMirtazapine
    70518-1309MirtazapineMirtazapine
    70518-1293MirtazapineMirtazapine
    70518-1838MirtazapineMirtazapine
    70518-1583MirtazapineMirtazapine
    70771-1072mirtazapinemirtazapine
    70771-1073mirtazapinemirtazapine
    70771-1074mirtazapinemirtazapine
    71335-0441MirtazapineMirtazapine
    71335-0286MirtazapineMirtazapine
    71335-0372MirtazapineMirtazapine
    71335-0717MirtazapineMirtazapine

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