NDC 64125-140

Glycopyrrolate

Glycopyrrolate

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

Product ID64125-140_a4aaf034-13f3-45f1-ba76-e6e34ab290c7
NDC64125-140
Product TypeHuman Prescription Drug
Proprietary NameGlycopyrrolate
Generic NameGlycopyrrolate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-10-01
Marketing CategoryANDA / ANDA
Application NumberANDA090195
Labeler NameExcellium Pharmaceutical, Inc.
Substance NameGLYCOPYRROLATE
Active Ingredient Strength2 mg/1
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 64125-140-01

100 TABLET in 1 BOTTLE (64125-140-01)
Marketing Start Date2012-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64125-140-01 [64125014001]

Glycopyrrolate TABLET
Marketing CategoryANDA
Application NumberANDA090195
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-10-01
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
GLYCOPYRROLATE2 mg/1

OpenFDA Data

SPL SET ID:6899ae9d-5981-4f01-9e55-cd88a79bb209
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197739
  • 197738
  • UPC Code
  • 0364125140011
  • 0364125139015
  • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]

    Medicade Reported Pricing

    64125014001 GLYCOPYRROLATE 2 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    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
    68001-353GlycopyrrolateGlycopyrrolate
    68001-351GlycopyrrolateGlycopyrrolate
    68001-352GlycopyrrolateGlycopyrrolate
    68001-354GlycopyrrolateGlycopyrrolate
    68151-0614GlycopyrrolateGlycopyrrolate
    0517-4602GlycopyrrolateGlycopyrrolate
    0517-4605GlycopyrrolateGlycopyrrolate
    0517-4620GlycopyrrolateGlycopyrrolate
    69076-475GLYCOPYRROLATEGLYCOPYRROLATE
    69076-476GLYCOPYRROLATEGLYCOPYRROLATE
    69067-050GlycopyrrolateGlycopyrrolate
    69315-140GlycopyrrolateGlycopyrrolate
    69315-139GlycopyrrolateGlycopyrrolate
    70069-012GlycopyrrolateGlycopyrrolate
    70121-1397GlycopyrrolateGlycopyrrolate
    70121-1395GlycopyrrolateGlycopyrrolate
    70121-1394GlycopyrrolateGlycopyrrolate
    70069-014GlycopyrrolateGlycopyrrolate
    70069-011GlycopyrrolateGlycopyrrolate
    70069-013GlycopyrrolateGlycopyrrolate
    70121-1396GlycopyrrolateGlycopyrrolate
    71335-0020GlycopyrrolateGlycopyrrolate
    71361-003GlycopyrrolateGlycopyrrolate
    71361-002GlycopyrrolateGlycopyrrolate
    71361-004GlycopyrrolateGlycopyrrolate
    71872-7152GlycopyrrolateGlycopyrrolate
    71361-001GlycopyrrolateGlycopyrrolate
    71872-7148GlycopyrrolateGlycopyrrolate
    71872-7012GlycopyrrolateGlycopyrrolate
    71872-7093GlycopyrrolateGlycopyrrolate
    71872-7094GlycopyrrolateGlycopyrrolate
    76045-203GlycopyrrolateGlycopyrrolate
    0615-8170GlycopyrrolateGlycopyrrolate
    0641-6034GlycopyrrolateGlycopyrrolate

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