NDC 0378-1005

Azathioprine

Azathioprine

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

Product ID0378-1005_115be871-5d6e-4bc9-a471-73bbe6f46341
NDC0378-1005
Product TypeHuman Prescription Drug
Proprietary NameAzathioprine
Generic NameAzathioprine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-12-28
Marketing CategoryANDA / ANDA
Application NumberANDA075568
Labeler NameMylan Pharmaceuticals Inc.
Substance NameAZATHIOPRINE
Active Ingredient Strength50 mg/1
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleosides [CS],Purine Antimetabolite [EPC],Purines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-1005-01

100 TABLET in 1 BOTTLE, PLASTIC (0378-1005-01)
Marketing Start Date2009-12-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-1005-01 [00378100501]

Azathioprine TABLET
Marketing CategoryANDA
Application NumberANDA075568
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-12-28

Drug Details

Active Ingredients

IngredientStrength
AZATHIOPRINE50 mg/1

OpenFDA Data

SPL SET ID:0a83e716-b688-433f-ac27-ae95132810cf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197388
  • Pharmacological Class

    • Nucleoside Analog [EXT]
    • Purine Antimetabolite [EPC]
    • Purines [CS]
    • Nucleic Acid Synthesis Inhibitors [MoA]
    • Nucleic Acid Synthesis Inhibitors [MoA]
    • Nucleosides [CS]
    • Purine Antimetabolite [EPC]
    • Purines [CS]

    NDC Crossover Matching brand name "Azathioprine" or generic name "Azathioprine"

    NDCBrand NameGeneric Name
    0378-1005Azathioprineazathioprine
    0615-7568AzathioprineAzathioprine
    21695-484AzathioprineAzathioprine
    33261-758AzathioprineAzathioprine
    42291-071AZATHIOPRINEAzathioprine
    43353-745Azathioprineazathioprine
    51079-620Azathioprineazathioprine
    51407-182AzathioprineAzathioprine
    60219-1076AZATHIOPRINEAzathioprine
    60219-2036AZATHIOPRINEAzathioprine
    60219-2037AZATHIOPRINEAzathioprine
    65841-602AzathioprineAzathioprine
    68084-229AzathioprineAzathioprine
    68382-118AzathioprineAzathioprine
    68382-119AzathioprineAzathioprine
    68382-120AzathioprineAzathioprine
    68382-003AzathioprineAzathioprine
    68462-502AzathioprineAzathioprine
    69238-1076AZATHIOPRINEAZATHIOPRINE
    70771-1141AzathioprineAzathioprine
    70771-1140AzathioprineAzathioprine
    70771-1139AzathioprineAzathioprine
    71610-124AZATHIOPRINEAZATHIOPRINE
    71610-306AzathioprineAzathioprine
    67877-494AzathioprineAzathioprine
    67877-495AzathioprineAzathioprine
    67877-492AzathioprineAzathioprine
    67877-493AzathioprineAzathioprine
    72789-129AZATHIOPRINEAZATHIOPRINE
    65649-231AzasanAzathioprine
    65649-241AzasanAzathioprine
    54766-590IMURANazathioprine
    65483-590IMURANazathioprine

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