NDC 0904-6519

Mirtazapine

Mirtazapine

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

Product ID0904-6519_1b299adf-51a9-4bf5-95f0-2c0a017dd031
NDC0904-6519
Product TypeHuman Prescription Drug
Proprietary NameMirtazapine
Generic NameMirtazapine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2007-08-22
Marketing CategoryANDA / ANDA
Application NumberANDA077666
Labeler NameMajor Pharmaceuticals
Substance NameMIRTAZAPINE
Active Ingredient Strength15 mg/1
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 0904-6519-61

100 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-6519-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2007-08-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6519-61 [00904651961]

Mirtazapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077666
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-08-22

Drug Details

Active Ingredients

IngredientStrength
MIRTAZAPINE15 mg/1

OpenFDA Data

SPL SET ID:a80463be-f2d2-4074-9bd8-5e52b0832b3a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311725
  • 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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