NDC 59630-205

Robinul Forte

Glycopyrrolate

Robinul Forte is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Shionogi Inc.. The primary component is Glycopyrrolate.

Product ID59630-205_81777c49-9cf0-4835-b791-1b7776d70af9
NDC59630-205
Product TypeHuman Prescription Drug
Proprietary NameRobinul Forte
Generic NameGlycopyrrolate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1961-03-28
Marketing CategoryNDA / NDA
Application NumberNDA012827
Labeler NameShionogi Inc.
Substance NameGLYCOPYRROLATE
Active Ingredient Strength2 mg/1
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 59630-205-10

100 TABLET in 1 BOTTLE (59630-205-10)
Marketing Start Date1961-03-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59630-205-10 [59630020510]

Robinul Forte TABLET
Marketing CategoryNDA
Application NumberNDA012827
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1961-03-28
Marketing End Date2017-06-13
Inactivation Date2019-11-13
Reactivation Date2019-12-12

Drug Details

Active Ingredients

IngredientStrength
GLYCOPYRROLATE2 mg/1

OpenFDA Data

SPL SET ID:bd65ee5e-2000-423c-b0a6-72eb213455c4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 102166
  • 197738
  • 197739
  • 205886

    • Pharmacological Class

    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]

    NDC Crossover Matching brand name "Robinul Forte" or generic name "Glycopyrrolate"

    NDCBrand NameGeneric Name
    59630-205Robinul ForteRobinul Forte
    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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