NDC 59547-210

Glycate

Glycopyrrolate

Glycate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Nuro Pharma, Inc.. The primary component is Glycopyrrolate.

Product ID59547-210_045baa49-d22c-4ed8-8dd6-b90565eca017
NDC59547-210
Product TypeHuman Prescription Drug
Proprietary NameGlycate
Generic NameGlycopyrrolate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-03-12
Marketing CategoryANDA / ANDA
Application NumberANDA091522
Labeler NameNuro Pharma, Inc.
Substance NameGLYCOPYRROLATE
Active Ingredient Strength2 mg/1
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 59547-210-19

100 TABLET in 1 BOTTLE, PLASTIC (59547-210-19)
Marketing Start Date2012-03-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59547-210-19 [59547021019]

Glycate TABLET
Marketing CategoryANDA
Application NumberANDA091522
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-03-12
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
GLYCOPYRROLATE1.5 mg/1

OpenFDA Data

SPL SET ID:045baa49-d22c-4ed8-8dd6-b90565eca017
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1247658
  • 1437975
    • UPC Code
  • 0359547210190

    • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]

    NDC Crossover Matching brand name "Glycate" or generic name "Glycopyrrolate"

    NDCBrand NameGeneric Name
    15370-160GLYCATEGLYCATE
    59547-210GlycateGlycate
    0259-0501Cuvposaglycopyrrolate
    0143-1250GlycopyrrolateGlycopyrrolate
    0143-1251GlycopyrrolateGlycopyrrolate
    0143-9584GlycopyrrolateGlycopyrrolate
    0143-9585GlycopyrrolateGlycopyrrolate
    0143-9586GlycopyrrolateGlycopyrrolate
    0143-9587GlycopyrrolateGlycopyrrolate
    0143-9679GlycopyrrolateGlycopyrrolate
    0143-9680GlycopyrrolateGlycopyrrolate
    0143-9681GlycopyrrolateGlycopyrrolate
    0143-9682GlycopyrrolateGlycopyrrolate
    0259-0502GlycopyrrolateGlycopyrrolate
    0404-9867GLYCOPYRROLATEGLYCOPYRROLATE
    0404-9868GLYCOPYRROLATEGLYCOPYRROLATE
    0404-9869GLYCOPYRROLATEGLYCOPYRROLATE
    0404-9870GLYCOPYRROLATEglycopyrrolate
    0517-4601GlycopyrrolateGlycopyrrolate
    0078-0662SEEBRI NEOHALERglycopyrrolate

    Trademark Results [Glycate]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    GLYCATE
    GLYCATE
    85773181 4506691 Live/Registered
    Argent Development Group, LLC
    2012-11-06
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