NDC 63629-5537

Mirtazapine

Mirtazapine

Mirtazapine is a Oral Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Mirtazapine.

Product ID63629-5537_0e61cdd6-1a33-4ccb-8933-23db67b0339e
NDC63629-5537
Product TypeHuman Prescription Drug
Proprietary NameMirtazapine
Generic NameMirtazapine
Dosage FormTablet, Orally Disintegrating
Route of AdministrationORAL
Marketing Start Date2006-02-28
Marketing CategoryANDA / ANDA
Application NumberANDA077376
Labeler NameBryant Ranch Prepack
Substance NameMIRTAZAPINE
Active Ingredient Strength45 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63629-5537-1

30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63629-5537-1)
Marketing Start Date2015-02-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-5537-1 [63629553701]

Mirtazapine TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA077376
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-02-03
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
MIRTAZAPINE45 mg/1

OpenFDA Data

SPL SET ID:218c5193-fde1-4782-b07a-ae513b2e85d3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 283485
  • 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.