NDC 0078-0662

SEEBRI NEOHALER

Glycopyrrolate

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

Product ID0078-0662_77c83e67-16ea-4b70-bfe8-e2a03926e278
NDC0078-0662
Product TypeHuman Prescription Drug
Proprietary NameSEEBRI NEOHALER
Generic NameGlycopyrrolate
Dosage FormCapsule
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2015-10-29
Marketing End Date2019-06-30
Marketing CategoryNDA / NDA
Application NumberNDA207923
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameGLYCOPYRROLATE
Active Ingredient Strength16 ug/1
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN

Packaging

NDC 0078-0662-19

60 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0662-19) > 1 CAPSULE in 1 BLISTER PACK (0078-0662-61)
Marketing Start Date2015-10-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0662-61 [00078066261]

SEEBRI NEOHALER CAPSULE
Marketing CategoryNDA
Application NumberNDA207923
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-10-29
Marketing End Date2019-06-30

NDC 0078-0662-06 [00078066206]

SEEBRI NEOHALER CAPSULE
Marketing CategoryNDA
Application NumberNDA207923
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-10-29
Marketing End Date2019-06-30

NDC 0078-0662-19 [00078066219]

SEEBRI NEOHALER CAPSULE
Marketing CategoryNDA
Application NumberNDA207923
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-10-29
Marketing End Date2019-06-30

Drug Details

Active Ingredients

IngredientStrength
GLYCOPYRROLATE15.6 ug/1

OpenFDA Data

SPL SET ID:8839674f-26d6-4302-9da0-258decfba9aa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1721308
  • 1721303

    • 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.