NDC 59212-705

Salagen

Pilocarpine Hydrochloride

Salagen is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Concordia Pharmaceuticals Inc.. The primary component is Pilocarpine Hydrochloride.

Product ID59212-705_0d620f3c-9619-4d6c-a407-da9f700db6c9
NDC59212-705
Product TypeHuman Prescription Drug
Proprietary NameSalagen
Generic NamePilocarpine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-09-01
Marketing CategoryNDA / NDA
Application NumberNDA020237
Labeler NameConcordia Pharmaceuticals Inc.
Substance NamePILOCARPINE HYDROCHLORIDE
Active Ingredient Strength5 mg/1
Pharm ClassesCholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 59212-705-10

100 TABLET, FILM COATED in 1 BOTTLE (59212-705-10)
Marketing Start Date2019-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59212-705-10 [59212070510]

Salagen TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020237
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-09-01

Drug Details

Active Ingredients

IngredientStrength
PILOCARPINE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:62eda83d-d043-4c7e-8fcf-75d05efbf35b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1000915
  • 1001006
  • 1001004
  • 1000913
    • UPC Code
  • 0359212705105

    • Pharmacological Class

    • Cholinergic Agonists [MoA]
    • Cholinergic Muscarinic Agonists [MoA]
    • Cholinergic Receptor Agonist [EPC]
    • Cholinergic Agonists [MoA]
    • Cholinergic Muscarinic Agonists [MoA]
    • Cholinergic Receptor Agonist [EPC]

    NDC Crossover Matching brand name "Salagen" or generic name "Pilocarpine Hydrochloride"

    NDCBrand NameGeneric Name
    62856-705SalagenSalagen
    62856-775SalagenSalagen
    59212-705SalagenSalagen
    59212-775SalagenSalagen
    0998-0203ISOPTO CARPINEpilocarpine hydrochloride
    0998-0204ISOPTO CARPINEpilocarpine hydrochloride
    0998-0206ISOPTO CARPINEpilocarpine hydrochloride
    0115-5911Pilocarpine HydrochloridePILOCARPINE HYDROCHLORIDE
    0115-5922Pilocarpine HydrochloridePILOCARPINE HYDROCHLORIDE
    0228-2801Pilocarpine hydrochloridePilocarpine hydrochloride
    0228-2837Pilocarpine hydrochloridePilocarpine hydrochloride
    0527-1313Pilocarpine HydrochloridePilocarpine Hydrochloride
    0527-1407Pilocarpine HydrochloridePilocarpine Hydrochloride
    10135-589Pilocarpine HydrochloridePilocarpine Hydrochloride
    10135-590Pilocarpine HydrochloridePilocarpine Hydrochloride
    10135-680Pilocarpine HydrochloridePilocarpine Hydrochloride
    16714-121Pilocarpine Hydrochloridepilocarpine hydrochloride
    16714-122Pilocarpine Hydrochloridepilocarpine hydrochloride
    17478-223Pilocarpine HydrochloridePilocarpine Hydrochloride
    17478-224Pilocarpine HydrochloridePilocarpine Hydrochloride
    0074-7098VUITYPilocarpine Hydrochloride

    Trademark Results [Salagen]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SALAGEN
    SALAGEN
    74120609 1753114 Live/Registered
    EISAI INC.
    1990-12-04
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.