NDC 57664-501

Mirtazapine

Mirtazapine

Mirtazapine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Mirtazapine.

Product ID57664-501_03b7bdc7-cf87-432a-bc7b-1ad74094ff8f
NDC57664-501
Product TypeHuman Prescription Drug
Proprietary NameMirtazapine
Generic NameMirtazapine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2004-04-22
Marketing CategoryANDA / ANDA
Application NumberANDA076541
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameMIRTAZAPINE
Active Ingredient Strength45 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 57664-501-18

1000 TABLET in 1 BOTTLE (57664-501-18)
Marketing Start Date2017-04-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57664-501-18 [57664050118]

Mirtazapine TABLET
Marketing CategoryANDA
Application NumberANDA076541
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-04-22

NDC 57664-501-83 [57664050183]

Mirtazapine TABLET
Marketing CategoryANDA
Application NumberANDA076541
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2004-04-22

NDC 57664-501-13 [57664050113]

Mirtazapine TABLET
Marketing CategoryANDA
Application NumberANDA076541
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2004-04-22
Marketing End Date2016-01-14

NDC 57664-501-88 [57664050188]

Mirtazapine TABLET
Marketing CategoryANDA
Application NumberANDA076541
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2004-04-22
Marketing End Date2016-01-14

Drug Details

Active Ingredients

IngredientStrength
MIRTAZAPINE45 mg/1

OpenFDA Data

SPL SET ID:f23631be-c7ae-46e9-b771-a70be17bc9f0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311725
  • 311726
  • 476809
  • 314111
    • UPC Code
  • 0357664510834
  • 0357664500835
  • 0357664501832

    • Medicade Reported Pricing

    57664050183 MIRTAZAPINE 45 MG TABLET

    Pricing Unit: EA | Drug Type:

    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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