NDC 63323-578

Glycopyrrolate

Glycopyrrolate

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

Product ID63323-578_39c961d1-3bfa-4411-aed4-87671fb2b8ba
NDC63323-578
Product TypeHuman Prescription Drug
Proprietary NameGlycopyrrolate
Generic NameGlycopyrrolate
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2017-10-27
Marketing CategoryANDA / ANDA
Application NumberANDA209328
Labeler NameFresenius Kabi USA, LLC
Substance NameGLYCOPYRROLATE
Active Ingredient Strength0 mg/mL
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63323-578-01

25 VIAL, SINGLE-DOSE in 1 CARTON (63323-578-01) > 1 mL in 1 VIAL, SINGLE-DOSE (63323-578-03)
Marketing Start Date2017-10-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-578-20 [63323057820]

Glycopyrrolate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA209328
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-10-27

NDC 63323-578-11 [63323057811]

Glycopyrrolate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA209328
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-10-27

NDC 63323-578-07 [63323057807]

Glycopyrrolate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA209328
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-10-27

NDC 63323-578-03 [63323057803]

Glycopyrrolate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA209328
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-10-27

NDC 63323-578-42 [63323057842]

Glycopyrrolate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA209328
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-10-27

NDC 63323-578-05 [63323057805]

Glycopyrrolate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA209328
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-10-27

NDC 63323-578-41 [63323057841]

Glycopyrrolate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA209328
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-10-27

NDC 63323-578-02 [63323057802]

Glycopyrrolate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA209328
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-10-27

NDC 63323-578-12 [63323057812]

Glycopyrrolate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA209328
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-10-27

NDC 63323-578-18 [63323057818]

Glycopyrrolate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA209328
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-10-27

NDC 63323-578-01 [63323057801]

Glycopyrrolate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA209328
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-10-27

NDC 63323-578-04 [63323057804]

Glycopyrrolate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA209328
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-10-27

Drug Details

Active Ingredients

IngredientStrength
GLYCOPYRROLATE.2 mg/mL

OpenFDA Data

SPL SET ID:ccafb5c2-86dd-4bb2-883a-c13e3171227c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238212
  • 1731590
  • 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
    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
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