NDC 55150-293

Glycopyrrolate

Glycopyrrolate

Glycopyrrolate is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Auromedics Pharma Llc. The primary component is Glycopyrrolate.

Product ID55150-293_eaebb511-1738-4d11-b9bb-317a8d41316a
NDC55150-293
Product TypeHuman Prescription Drug
Proprietary NameGlycopyrrolate
Generic NameGlycopyrrolate
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2018-11-28
Marketing CategoryANDA / ANDA
Application NumberANDA210244
Labeler NameAuroMedics Pharma LLC
Substance NameGLYCOPYRROLATE
Active Ingredient Strength0 mg/mL
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55150-293-02

25 VIAL, SINGLE-DOSE in 1 CARTON (55150-293-02) > 2 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-11-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55150-293-02 [55150029302]

Glycopyrrolate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA210244
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-11-28

Drug Details

Active Ingredients

IngredientStrength
GLYCOPYRROLATE.2 mg/mL

OpenFDA Data

SPL SET ID:eaebb511-1738-4d11-b9bb-317a8d41316a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238212
  • 1731590
  • 1731582
  • UPC Code
  • 0355150295203
  • 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.