NDC 52584-682

GLYCOPYRROLATE

Glycopyrrolate

GLYCOPYRROLATE is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by General Injectables And Vaccines, Inc.. The primary component is Glycopyrrolate.

Product ID52584-682_5179b1b9-6b74-4a41-8d54-51191af6c292
NDC52584-682
Product TypeHuman Prescription Drug
Proprietary NameGLYCOPYRROLATE
Generic NameGlycopyrrolate
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2018-07-02
Marketing CategoryANDA / ANDA
Application NumberANDA090963
Labeler NameGeneral Injectables and Vaccines, Inc.
Substance NameGLYCOPYRROLATE
Active Ingredient Strength0 mg/mL
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 52584-682-01

1 VIAL in 1 BAG (52584-682-01) > 1 mL in 1 VIAL
Marketing Start Date2018-07-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-682-01 [52584068201]

GLYCOPYRROLATE INJECTION
Marketing CategoryANDA
Application NumberANDA090963
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-02

Drug Details

Active Ingredients

IngredientStrength
GLYCOPYRROLATE.2 mg/mL

OpenFDA Data

SPL SET ID:ac6faa40-8a41-448d-ab41-3ba8551fca72
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1731582
  • 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
    0517-4601GlycopyrrolateGlycopyrrolate
    0517-4602GlycopyrrolateGlycopyrrolate
    0517-4605GlycopyrrolateGlycopyrrolate
    0517-4620GlycopyrrolateGlycopyrrolate
    0615-8170Glycopyrrolateglycopyrrolate
    0641-6033GlycopyrrolateGlycopyrrolate
    0641-6034GlycopyrrolateGlycopyrrolate
    0641-6035GlycopyrrolateGlycopyrrolate
    0641-6036GlycopyrrolateGlycopyrrolate
    0722-7097GlycopyrrolateGlycopyrrolate
    0781-3825GlycopyrrolateGlycopyrrolate
    0781-3827GlycopyrrolateGlycopyrrolate
    0781-3829GlycopyrrolateGlycopyrrolate
    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

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