NDC 15370-160

GLYCATE

Glycopyrrolate

GLYCATE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Carwin Pharmaceutical Associates, Llc. The primary component is Glycopyrrolate.

Product ID15370-160_80af968f-ed60-44e5-9345-e8773f65f0e4
NDC15370-160
Product TypeHuman Prescription Drug
Proprietary NameGLYCATE
Generic NameGlycopyrrolate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-06-10
Marketing CategoryANDA / ANDA
Application NumberANDA091522
Labeler NameCarwin Pharmaceutical Associates, LLC
Substance NameGLYCOPYRROLATE
Active Ingredient Strength2 mg/1
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 15370-160-03

3 TABLET in 1 BOTTLE, PLASTIC (15370-160-03)
Marketing Start Date2018-06-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 15370-160-03 [15370016003]

GLYCATE TABLET
Marketing CategoryANDA
Application NumberANDA091522
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-10

NDC 15370-160-10 [15370016010]

GLYCATE TABLET
Marketing CategoryANDA
Application NumberANDA091522
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-10

Drug Details

Active Ingredients

IngredientStrength
GLYCOPYRROLATE1.5 mg/1

OpenFDA Data

SPL SET ID:8f5dfdb4-67cc-42b5-85fd-0d4e50f66fe8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1247658
  • 1437975
    • UPC Code
  • 0315370160101

    • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]
    • 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.