NDC 67386-821

Northera

Droxidopa

Northera is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Lundbeck Pharmaceuticals Llc. The primary component is Droxidopa.

Product ID67386-821_3db0def7-9429-4cba-855b-1c571ce65379
NDC67386-821
Product TypeHuman Prescription Drug
Proprietary NameNorthera
Generic NameDroxidopa
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2014-09-01
Marketing CategoryNDA / NDA
Application NumberNDA203202
Labeler NameLundbeck Pharmaceuticals LLC
Substance NameDROXIDOPA
Active Ingredient Strength200 mg/1
Pharm ClassesCatecholamines [CS],Increased Blood Pressure [PE]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 67386-821-19

90 CAPSULE in 1 BOTTLE (67386-821-19)
Marketing Start Date2014-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67386-821-19 [67386082119]

Northera CAPSULE
Marketing CategoryNDA
Application NumberNDA203202
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-09-01

Drug Details

Active Ingredients

IngredientStrength
DROXIDOPA200 mg/1

OpenFDA Data

SPL SET ID:2179f02c-48d7-48eb-8007-5ae43d8d16bc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1490040
  • 1490032
  • 1490026
  • 1490036
  • 1490034
  • 1490038
  • Pharmacological Class

    • Catecholamines [CS]
    • Increased Blood Pressure [PE]

    NDC Crossover Matching brand name "Northera" or generic name "Droxidopa"

    NDCBrand NameGeneric Name
    67386-820Northeradroxidopa
    67386-821Northeradroxidopa
    67386-822Northeradroxidopa
    0054-0532DroxidopaDroxidopa
    0054-0533DroxidopaDroxidopa
    0054-0534DroxidopaDroxidopa
    0832-0720DroxidopaDroxidopa
    0832-0721DroxidopaDroxidopa
    0832-0722DroxidopaDroxidopa
    27241-199DroxidopaDroxidopa
    27241-200DroxidopaDroxidopa
    27241-201DroxidopaDroxidopa
    27808-199droxidopadroxidopa
    27808-200droxidopadroxidopa
    27808-201droxidopadroxidopa
    31722-010DroxidopaDroxidopa
    31722-014DroxidopaDroxidopa
    31722-015DroxidopaDroxidopa
    50228-429Droxidopadroxidopa
    50228-430Droxidopadroxidopa
    50228-431Droxidopadroxidopa
    59651-375DroxidopaDroxidopa
    59651-376DroxidopaDroxidopa
    59651-377DroxidopaDroxidopa
    63304-086droxidopadroxidopa
    63304-104droxidopadroxidopa
    63304-112droxidopadroxidopa

    Trademark Results [Northera]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NORTHERA
    NORTHERA
    86922745 5054515 Live/Registered
    Lundbeck NA Ltd.
    2016-02-29
    NORTHERA
    NORTHERA
    85340343 4684974 Live/Registered
    LUNDBECK NA LTD.
    2011-06-07
    NORTHERA
    NORTHERA
    77295310 not registered Dead/Abandoned
    Chelsea Therapeutics, Inc.
    2007-10-03

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