NDC 0187-3013

Mestinon

Pyridostigmine Bromide

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

Product ID0187-3013_2cf4c907-e7e1-4182-a7b5-d0b7fb13efa3
NDC0187-3013
Product TypeHuman Prescription Drug
Proprietary NameMestinon
Generic NamePyridostigmine Bromide
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date1959-01-12
Marketing CategoryNDA / NDA
Application NumberNDA011665
Labeler NameBausch Health Americas, Inc.
Substance NamePYRIDOSTIGMINE BROMIDE
Active Ingredient Strength180 mg/1
Pharm ClassesCholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0187-3013-30

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-3013-30)
Marketing Start Date1959-01-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0187-3013-30 [00187301330]

Mestinon TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA011665
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1959-01-12

Drug Details

Active Ingredients

IngredientStrength
PYRIDOSTIGMINE BROMIDE180 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.