NDC 62856-775

Salagen

Pilocarpine Hyrochloride

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

Product ID62856-775_13490d5b-0ef4-495a-9ba9-dbb9e209593f
NDC62856-775
Product TypeHuman Prescription Drug
Proprietary NameSalagen
Generic NamePilocarpine Hyrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1994-03-22
Marketing End Date2022-09-30
Marketing CategoryNDA / NDA
Application NumberNDA020237
Labeler NameEisai Inc.
Substance NamePILOCARPINE HYDROCHLORIDE
Active Ingredient Strength8 mg/1
Pharm ClassesCholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC]
NDC Exclude FlagN

Packaging

NDC 62856-775-10

100 TABLET, FILM COATED in 1 BOTTLE (62856-775-10)
Marketing Start Date1994-03-22
Marketing End Date2022-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62856-775-10 [62856077510]

Salagen TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020237
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1994-03-22
Marketing End Date2022-09-30

Drug Details

Active Ingredients

IngredientStrength
PILOCARPINE HYDROCHLORIDE7.5 mg/1

OpenFDA Data

SPL SET ID:fb4810ec-d26f-429d-b87c-5898a7870169
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1000915
  • 1001006
  • 1001004
  • 1000913
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    59212-705SalagenPilocarpine Hydrochloride
    59212-775SalagenPilocarpine Hydrochloride
    62856-705Salagenpilocarpine hyrochloride
    62856-775Salagenpilocarpine hyrochloride

    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.