NDC 71361-004

Glycopyrrolate

Glycopyrrolate

Glycopyrrolate is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Piramal Critical Care Limited. The primary component is Glycopyrrolate.

Product ID71361-004_d88bde86-2e3e-4d3c-bdac-952003e0706f
NDC71361-004
Product TypeHuman Prescription Drug
Proprietary NameGlycopyrrolate
Generic NameGlycopyrrolate
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2018-07-24
Marketing CategoryANDA / ANDA
Application NumberANDA210842
Labeler NamePiramal Critical Care Limited
Substance NameGLYCOPYRROLATE
Active Ingredient Strength0 mg/mL
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 71361-004-10

10 VIAL, GLASS in 1 CARTON (71361-004-10) > 20 mL in 1 VIAL, GLASS (71361-004-01)
Marketing Start Date2018-07-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71361-004-10 [71361000410]

Glycopyrrolate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA210842
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-24
Marketing End Date2019-08-30

NDC 71361-004-01 [71361000401]

Glycopyrrolate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA210842
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-24
Marketing End Date2019-08-30

Drug Details

Active Ingredients

IngredientStrength
GLYCOPYRROLATE.2 mg/mL

OpenFDA Data

SPL SET ID:273d3cff-3fe6-4269-b1ce-e9c8306a38fb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238212
  • 1731590
  • 1731582
  • UPC Code
  • 0371361004014
  • 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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