NDC 0187-0453

ZELAPAR

Selegiline Hydrochloride

ZELAPAR is a Oral Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Valeant Pharmaceuticals North America Llc. The primary component is Selegiline Hydrochloride.

Product ID0187-0453_225214d6-9a64-4a5c-91d8-3095f4f14ad8
NDC0187-0453
Product TypeHuman Prescription Drug
Proprietary NameZELAPAR
Generic NameSelegiline Hydrochloride
Dosage FormTablet, Orally Disintegrating
Route of AdministrationORAL
Marketing Start Date2006-06-14
Marketing CategoryNDA / NDA
Application NumberNDA021479
Labeler NameValeant Pharmaceuticals North America LLC
Substance NameSELEGILINE HYDROCHLORIDE
Active Ingredient Strength1 mg/1
Pharm ClassesMonoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0187-0453-02

6 POUCH in 1 CARTON (0187-0453-02) > 10 TABLET, ORALLY DISINTEGRATING in 1 POUCH
Marketing Start Date2006-06-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0187-0453-02 [00187045302]

ZELAPAR TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA021479
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-06-14

NDC 0187-0453-03 [00187045303]

ZELAPAR TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA021479
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-06-14
Marketing End Date2019-06-30

Drug Details

Active Ingredients

IngredientStrength
SELEGILINE HYDROCHLORIDE1.25 mg/1

OpenFDA Data

SPL SET ID:380d7717-2a79-42f3-a712-efe5e7696ba0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 859192
  • 859190

    • Pharmacological Class

    • Monoamine Oxidase Inhibitor [EPC]
    • Monoamine Oxidase Inhibitors [MoA]
    • Monoamine Oxidase Type B Inhibitor [EPC]
    • Monoamine Oxidase-B Inhibitors [MoA]

    NDC Crossover Matching brand name "ZELAPAR" or generic name "Selegiline Hydrochloride"

    NDCBrand NameGeneric Name
    0187-0453ZELAPARSELEGILINE HYDROCHLORIDE
    0378-9290Selegiline Hydrochlorideselegiline hydrochloride
    10135-737Selegiline HydrochlorideSelegiline Hydrochloride
    16571-659Selegiline HydrochlorideSelegiline Hydrochloride
    50090-2918Selegiline HydrochlorideSelegiline Hydrochloride
    51862-146Selegiline HydrochlorideSelegiline Hydrochloride
    60429-019SELEGILINE HYDROCHLORIDESELEGILINE HYDROCHLORIDE
    60429-176Selegiline HydrochlorideSelegiline Hydrochloride
    60505-0055SELEGILINE HYDROCHLORIDESELEGILINE HYDROCHLORIDE
    60505-3438Selegiline HydrochlorideSelegiline Hydrochloride
    67253-700SELEGILINE HYDROCHLORIDESELEGILINE HYDROCHLORIDE
    68151-2649SELEGILINE HYDROCHLORIDESELEGILINE HYDROCHLORIDE
    70954-504Selegiline HydrochlorideSelegiline Hydrochloride
    71205-888Selegiline HydrochlorideSelegiline Hydrochloride
    72319-006Selegiline HydrochlorideSelegiline Hydrochloride

    Trademark Results [ZELAPAR]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZELAPAR
    ZELAPAR
    76301259 3073895 Live/Registered
    VALEANT PHARMACEUTICALS NORTH AMERICA LLC
    2001-08-16
    ZELAPAR
    ZELAPAR
    75431857 not registered Dead/Abandoned
    Elan Pharmaceuticals, Inc.
    1998-02-10
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.