NDC 0187-3010

Mestinon

Pyridostigmine Bromide

Mestinon is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Americas, Inc.. The primary component is Pyridostigmine Bromide.

Product ID0187-3010_2cf4c907-e7e1-4182-a7b5-d0b7fb13efa3
NDC0187-3010
Product TypeHuman Prescription Drug
Proprietary NameMestinon
Generic NamePyridostigmine Bromide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1955-04-06
Marketing CategoryNDA / NDA
Application NumberNDA009829
Labeler NameBausch Health Americas, Inc.
Substance NamePYRIDOSTIGMINE BROMIDE
Active Ingredient Strength60 mg/1
Pharm ClassesCholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0187-3010-30

100 TABLET in 1 BOTTLE (0187-3010-30)
Marketing Start Date1995-04-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0187-3010-40 [00187301040]

Mestinon TABLET
Marketing CategoryNDA
Application NumberNDA009829
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1955-04-06
Marketing End Date2015-04-06

NDC 0187-3010-30 [00187301030]

Mestinon TABLET
Marketing CategoryNDA
Application NumberNDA009829
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1995-04-06

Drug Details

Active Ingredients

IngredientStrength
PYRIDOSTIGMINE BROMIDE60 mg/1

OpenFDA Data

SPL SET ID:a851795e-b7a8-40c3-9922-5e79d3eb4d92
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 903859
  • 903849
  • 903845
  • 903847
  • 903857
  • 903843

    • Pharmacological Class

    • Cholinesterase Inhibitor [EPC]
    • Cholinesterase Inhibitors [MoA]

    NDC Crossover Matching brand name "Mestinon" or generic name "Pyridostigmine Bromide"

    NDCBrand NameGeneric Name
    0187-3010Mestinonpyridostigmine bromide
    0187-3012Mestinonpyridostigmine bromide
    0187-3013Mestinonpyridostigmine bromide
    13811-716Pryidostigmine BromidePyridostigmine Bromide
    16571-833Pryidostigmine BromidePyridostigmine Bromide
    24689-104PRYIDOSTIGMINE BROMIDEpyridostigmine bromide
    0115-1404Pyridostigmine BromidePYRIDOSTIGMINE BROMIDE
    0115-2134Pyridostigmine BromidePYRIDOSTIGMINE BROMIDE
    0115-3511Pyridostigmine BromidePYRIDOSTIGMINE BROMIDE
    0904-6622pyridostigmine bromidepyridostigmine bromide
    47781-335Pyridostigmine BromidePyridostigmine Bromide
    0781-3040RegonolPyridostigmine Bromide

    Trademark Results [Mestinon]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MESTINON
    MESTINON
    71655783 0592950 Live/Registered
    HOFFMANN-LA ROCHE INC.
    1953-11-03
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.