NDC 0591-1119

Mirtazapine

Mirtazapine

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

Product ID0591-1119_24536a22-bf03-4b01-82c3-5b75c473b2b3
NDC0591-1119
Product TypeHuman Prescription Drug
Proprietary NameMirtazapine
Generic NameMirtazapine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2003-06-19
Marketing CategoryANDA / ANDA
Application NumberANDA076312
Labeler NameActavis Pharma, Inc.
Substance NameMIRTAZAPINE
Active Ingredient Strength45 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0591-1119-30

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-1119-30)
Marketing Start Date2003-06-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-1119-30 [00591111930]

Mirtazapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076312
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-06-19
Marketing End Date2020-03-31

NDC 0591-1119-10 [00591111910]

Mirtazapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076312
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-04-03
Marketing End Date2014-08-21

NDC 0591-1119-01 [00591111901]

Mirtazapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076312
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2003-06-19
Marketing End Date2003-06-19

NDC 0591-1119-05 [00591111905]

Mirtazapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076312
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2003-06-19
Marketing End Date2003-06-19

Drug Details

Active Ingredients

IngredientStrength
MIRTAZAPINE45 mg/1

OpenFDA Data

SPL SET ID:aecec663-16ed-4c34-a00a-af6b99b3e1b6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311725
  • 311726
  • 314111
    • UPC Code
  • 0305911119309
  • 0305911117305

    • 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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