NDC 0378-1270

Rasagiline Mesylate

Rasagiline Mesylate

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

Product ID0378-1270_100ee341-7166-4aeb-b571-d9b7b3546b0c
NDC0378-1270
Product TypeHuman Prescription Drug
Proprietary NameRasagiline Mesylate
Generic NameRasagiline Mesylate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-05-26
Marketing CategoryANDA / ANDA
Application NumberANDA201971
Labeler NameMylan Pharmaceuticals Inc.
Substance NameRASAGILINE MESYLATE
Active Ingredient Strength1 mg/1
Pharm ClassesMonoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0378-1270-93

30 TABLET in 1 BOTTLE, PLASTIC (0378-1270-93)
Marketing Start Date2017-05-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-1270-05 [00378127005]

Rasagiline Mesylate TABLET
Marketing CategoryANDA
Application NumberANDA201971
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-01
Marketing End Date2017-08-02

NDC 0378-1270-93 [00378127093]

Rasagiline Mesylate TABLET
Marketing CategoryANDA
Application NumberANDA201971
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-05-26

NDC 0378-1270-77 [00378127077]

Rasagiline Mesylate TABLET
Marketing CategoryANDA
Application NumberANDA201971
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-01
Marketing End Date2017-08-02

Drug Details

Active Ingredients

IngredientStrength
RASAGILINE MESYLATE.5 mg/1

OpenFDA Data

SPL SET ID:212ec349-2fbb-43dc-9dd1-745efddb52fa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 608328
  • 636664
  • Pharmacological Class

    • Monoamine Oxidase Inhibitor [EPC]
    • Monoamine Oxidase Inhibitors [MoA]

    NDC Crossover Matching brand name "Rasagiline Mesylate" or generic name "Rasagiline Mesylate"

    NDCBrand NameGeneric Name
    0378-1270Rasagiline Mesylaterasagiline mesylate
    0378-1271Rasagiline Mesylaterasagiline mesylate
    14445-104Rasagiline MesylateRasagiline Mesylate
    14445-105Rasagiline MesylateRasagiline Mesylate
    23155-746Rasagiline MesylateRasagiline Mesylate
    23155-747Rasagiline MesylateRasagiline Mesylate
    47781-138Rasagiline MesylateRasagiline Mesylate
    47781-139Rasagiline MesylateRasagiline Mesylate
    43353-015AzilectRasagiline Mesylate
    68546-142AzilectRasagiline mesylate
    68546-229AzilectRasagiline mesylate

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