NDC 50742-489

GLYCOPYRROLATE

Glycopyrrolate

GLYCOPYRROLATE is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Ingenus Pharmaceuticals, Llc. The primary component is Glycopyrrolate.

Product ID50742-489_8cb72674-1c75-4138-affb-9070e3b23817
NDC50742-489
Product TypeHuman Prescription Drug
Proprietary NameGLYCOPYRROLATE
Generic NameGlycopyrrolate
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-02-20
Marketing CategoryANDA / ANDA
Application NumberANDA210083
Labeler NameIngenus Pharmaceuticals, LLC
Substance NameGLYCOPYRROLATE
Active Ingredient Strength5 mg/20mL
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50742-489-21

10 VIAL in 1 CARTON (50742-489-21) > 20 mL in 1 VIAL (50742-489-20)
Marketing Start Date2020-02-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50742-489-21 [50742048921]

GLYCOPYRROLATE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA210083
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-20

NDC 50742-489-20 [50742048920]

GLYCOPYRROLATE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA210083
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-20

Drug Details

Active Ingredients

IngredientStrength
GLYCOPYRROLATE5 mg/20mL

OpenFDA Data

SPL SET ID:a2410c30-7857-465f-a508-315132d03a93
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238212
  • 1731590
  • 1731582
  • UPC Code
  • 0350742489213
  • 0350742486021
  • 0350742489206
  • 0350742488056
  • 0350742487028
  • 0350742488063
  • 0350742486014
  • 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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