NDC 0615-8170

Glycopyrrolate

Glycopyrrolate

Glycopyrrolate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Glycopyrrolate.

Product ID0615-8170_08c1a7a1-e1ee-492b-b6e0-04fe5cb4a102
NDC0615-8170
Product TypeHuman Prescription Drug
Proprietary NameGlycopyrrolate
Generic NameGlycopyrrolate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-07-10
Marketing CategoryANDA / ANDA
Application NumberANDA040653
Labeler NameNCS HealthCare of KY, Inc dba Vangard Labs
Substance NameGLYCOPYRROLATE
Active Ingredient Strength1 mg/1
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0615-8170-39

30 TABLET in 1 BLISTER PACK (0615-8170-39)
Marketing Start Date2018-07-10
Marketing End Date2021-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-8170-39 [00615817039]

Glycopyrrolate TABLET
Marketing CategoryANDA
Application NumberANDA040653
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-10
Marketing End Date2021-08-31

Drug Details

Active Ingredients

IngredientStrength
GLYCOPYRROLATE1 mg/1

OpenFDA Data

SPL SET ID:91fae7e5-7267-400b-9d49-a85e900b9fea
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197738
  • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]

    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
    0404-9867GLYCOPYRROLATEGLYCOPYRROLATE
    0404-9868GLYCOPYRROLATEGLYCOPYRROLATE
    0404-9869GLYCOPYRROLATEGLYCOPYRROLATE
    0404-9870GLYCOPYRROLATEglycopyrrolate
    0517-4601GlycopyrrolateGlycopyrrolate
    0517-4602GlycopyrrolateGlycopyrrolate
    0517-4605GlycopyrrolateGlycopyrrolate
    0517-4620GlycopyrrolateGlycopyrrolate
    0615-8170Glycopyrrolateglycopyrrolate
    68001-353GlycopyrrolateGlycopyrrolate
    68001-351GlycopyrrolateGlycopyrrolate
    68001-352GlycopyrrolateGlycopyrrolate
    68001-354GlycopyrrolateGlycopyrrolate
    68151-0614GlycopyrrolateGlycopyrrolate
    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
    0641-6034GlycopyrrolateGlycopyrrolate
    0641-6035GlycopyrrolateGlycopyrrolate

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