NDC 52959-902

Mirtazapine

Mirtazapine

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

Product ID52959-902_6dadb3b7-2077-4b27-b8b6-529e8698deca
NDC52959-902
Product TypeHuman Prescription Drug
Proprietary NameMirtazapine
Generic NameMirtazapine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2009-08-17
Marketing CategoryANDA / ANDA
Application NumberANDA076921
Labeler NameH.J. Harkins Company, Inc.
Substance NameMIRTAZAPINE
Active Ingredient Strength30 mg/1
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 52959-902-30

30 TABLET, FILM COATED in 1 BOTTLE (52959-902-30)
Marketing Start Date2009-08-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-902-30 [52959090230]

Mirtazapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076921
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-08-17
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
MIRTAZAPINE30 mg/1

OpenFDA Data

SPL SET ID:18a9c172-7081-484a-8c3b-bde9b2e54e95
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.