NDC 60687-458

Glycopyrrolate

Glycopyrrolate

Glycopyrrolate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by American Health Packaging. The primary component is Glycopyrrolate.

Product ID60687-458_9337d085-79af-0605-e053-2995a90a3920
NDC60687-458
Product TypeHuman Prescription Drug
Proprietary NameGlycopyrrolate
Generic NameGlycopyrrolate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-09-20
Marketing CategoryANDA / ANDA
Application NumberANDA202675
Labeler NameAmerican Health Packaging
Substance NameGLYCOPYRROLATE
Active Ingredient Strength1 mg/1
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 60687-458-01

100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-458-01) > 1 TABLET in 1 BLISTER PACK (60687-458-11)
Marketing Start Date2019-09-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60687-458-01 [60687045801]

Glycopyrrolate TABLET
Marketing CategoryANDA
Application NumberANDA202675
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-09-20

NDC 60687-458-11 [60687045811]

Glycopyrrolate TABLET
Marketing CategoryANDA
Application NumberANDA202675
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-09-20

Drug Details

Active Ingredients

IngredientStrength
GLYCOPYRROLATE1 mg/1

OpenFDA Data

SPL SET ID:6404fc8e-d109-4950-9dca-c8a85ad90cf3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197738
  • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]
    • 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
    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.