NDC 63402-815

SEEBRI NEOHALER

Glycopyrrolate

SEEBRI NEOHALER is a Respiratory (inhalation) Capsule in the Human Prescription Drug category. It is labeled and distributed by Sunovion Pharmacueticals Inc.. The primary component is Glycopyrrolate.

Product ID63402-815_8e67ef0c-bae2-404c-be17-0e6f401921de
NDC63402-815
Product TypeHuman Prescription Drug
Proprietary NameSEEBRI NEOHALER
Generic NameGlycopyrrolate
Dosage FormCapsule
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2017-10-29
Marketing End Date2021-10-31
Marketing CategoryNDA / NDA
Application NumberNDA207923
Labeler NameSunovion Pharmacueticals Inc.
Substance NameGLYCOPYRROLATE
Active Ingredient Strength16 ug/1
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN

Packaging

NDC 63402-815-06

1 BLISTER PACK in 1 CARTON (63402-815-06) > 6 CAPSULE in 1 BLISTER PACK (63402-815-01) > 1 CAPSULE in 1 CAPSULE
Marketing Start Date2017-12-01
Marketing End Date2021-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63402-815-02 [63402081502]

SEEBRI NEOHALER CAPSULE
Marketing CategoryNDA
Application NumberNDA207923
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-29
Marketing End Date2021-10-31

NDC 63402-815-01 [63402081501]

SEEBRI NEOHALER CAPSULE
Marketing CategoryNDA
Application NumberNDA207923
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-10-29
Marketing End Date2021-10-31

NDC 63402-815-06 [63402081506]

SEEBRI NEOHALER CAPSULE
Marketing CategoryNDA
Application NumberNDA207923
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-01
Marketing End Date2021-10-31

NDC 63402-815-12 [63402081512]

SEEBRI NEOHALER CAPSULE
Marketing CategoryNDA
Application NumberNDA207923
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-01
Marketing End Date2021-10-31

NDC 63402-815-60 [63402081560]

SEEBRI NEOHALER CAPSULE
Marketing CategoryNDA
Application NumberNDA207923
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-01
Marketing End Date2021-10-31

Drug Details

Active Ingredients

IngredientStrength
GLYCOPYRROLATE15.6 ug/1

OpenFDA Data

SPL SET ID:260e843d-a627-4cb1-8cab-4f0537d1ca5e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1721308
  • 1721303
  • UPC Code
  • 0363402815062
  • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]

    NDC Crossover Matching brand name "SEEBRI NEOHALER" or generic name "Glycopyrrolate"

    NDCBrand NameGeneric Name
    0078-0662SEEBRI NEOHALERglycopyrrolate
    63402-815SEEBRI NEOHALERSEEBRI NEOHALER
    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.