NDC 63402-201

LONHALA MAGNAIR

Glycopyrrolate

LONHALA MAGNAIR is a Respiratory (inhalation) Solution in the Human Prescription Drug category. It is labeled and distributed by Sunovion Pharmaceuticals Inc.. The primary component is Glycopyrrolate.

Product ID63402-201_4fa161dc-dc13-48d4-b0fb-d89684f43b24
NDC63402-201
Product TypeHuman Prescription Drug
Proprietary NameLONHALA MAGNAIR
Generic NameGlycopyrrolate
Dosage FormSolution
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2018-01-29
Marketing CategoryNDA / NDA
Application NumberNDA208437
Labeler NameSunovion Pharmaceuticals Inc.
Substance NameGLYCOPYRROLATE
Active Ingredient Strength25 ug/mL
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63402-201-00

1 CARTON in 1 KIT (63402-201-00) > 30 POUCH in 1 CARTON > 2 VIAL, SINGLE-DOSE in 1 POUCH > 1 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-01-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63402-201-01 [63402020101]

LONHALA MAGNAIR SOLUTION
Marketing CategoryNDA
Application NumberNDA208437
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-05
Marketing End Date2018-01-30

NDC 63402-201-00 [63402020100]

LONHALA MAGNAIR SOLUTION
Marketing CategoryNDA
Application NumberNDA208437
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-01-29

Drug Details

Active Ingredients

IngredientStrength
GLYCOPYRROLATE25 ug/mL

OpenFDA Data

SPL SET ID:78166def-5e2f-42a6-a1f1-0253e5765632
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1992571
  • 1992566
    • UPC Code
  • 0363402101028

    • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]

    Medicade Reported Pricing

    63402020100 LONHALA MAGNAIR 25 MCG STARTER

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "LONHALA MAGNAIR" or generic name "Glycopyrrolate"

    NDCBrand NameGeneric Name
    63402-301LONHALA MAGNAIRLONHALA MAGNAIR
    63402-201LONHALA MAGNAIRLONHALA MAGNAIR
    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
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