NDC 0378-3545

Mirtazapine

Mirtazapine

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

Product ID0378-3545_1d8538f0-2f99-4a5f-99dc-9fe40817d513
NDC0378-3545
Product TypeHuman Prescription Drug
Proprietary NameMirtazapine
Generic NameMirtazapine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2003-06-20
Marketing CategoryANDA / ANDA
Application NumberANDA076122
Labeler NameMylan Pharmaceuticals Inc.
Substance NameMIRTAZAPINE
Active Ingredient Strength45 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0378-3545-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3545-01)
Marketing Start Date2016-08-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-3545-93 [00378354593]

Mirtazapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076122
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-06-20

NDC 0378-3545-70 [00378354570]

Mirtazapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076122
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-06-20

NDC 0378-3545-01 [00378354501]

Mirtazapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076122
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-08-02

NDC 0378-3545-05 [00378354505]

Mirtazapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076122
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-06-20

Drug Details

Active Ingredients

IngredientStrength
MIRTAZAPINE45 mg/1

OpenFDA Data

SPL SET ID:711aa80b-8fc6-49e6-9494-3db31d9b53a4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311725
  • 311726
  • 314111

    • 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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