NDC 51754-6000

GLYRX-PF

Glycopyrrolate

GLYRX-PF is a Intramuscular; Intravitreal Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Exela Pharma Sciences, Llc. The primary component is Glycopyrrolate.

Product ID51754-6000_140aa855-b56a-493b-b94e-e4f429b5ba48
NDC51754-6000
Product TypeHuman Prescription Drug
Proprietary NameGLYRX-PF
Generic NameGlycopyrrolate
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVITREAL
Marketing Start Date2018-08-01
Marketing CategoryNDA / NDA
Application NumberNDA210997
Labeler NameExela Pharma Sciences, LLC
Substance NameGLYCOPYRROLATE
Active Ingredient Strength0 mg/mL
Pharm ClassesAnticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 51754-6000-4

25 VIAL, SINGLE-DOSE in 1 CARTON (51754-6000-4) > 1 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51754-6000-4 [51754600004]

GLYRX-PF INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA210997
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-08-01

Drug Details

Active Ingredients

IngredientStrength
GLYCOPYRROLATE.2 mg/mL

OpenFDA Data

SPL SET ID:2189f3f5-39dc-4e85-b7c6-9515ded59686
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1731590
  • 1731582

    • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]

    NDC Crossover Matching brand name "GLYRX-PF" or generic name "Glycopyrrolate"

    NDCBrand NameGeneric Name
    51754-6000GLYRX-PFGLYRX-PF
    51754-6001GLYRX-PFGLYRX-PF
    51754-6015GLYRX-PFGLYRX-PF
    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 [GLYRX-PF]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    GLYRX-PF
    GLYRX-PF
    88628629 not registered Live/Pending
    Exela Holdings, Inc.
    2019-09-24
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