NDC 67386-211

SABRIL

Vigabatrin

SABRIL is a Oral Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Lundbeck Pharmaceuticals Llc. The primary component is Vigabatrin.

Product ID67386-211_09482f56-a17c-4a05-8faf-378f6f1d69b5
NDC67386-211
Product TypeHuman Prescription Drug
Proprietary NameSABRIL
Generic NameVigabatrin
Dosage FormPowder, For Solution
Route of AdministrationORAL
Marketing Start Date2009-08-21
Marketing CategoryNDA / NDA
Application NumberNDA022006
Labeler NameLundbeck Pharmaceuticals LLC
Substance NameVIGABATRIN
Active Ingredient Strength50 mg/mL
Pharm ClassesAnti-epileptic Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 67386-211-65

50 PACKET in 1 CARTON (67386-211-65) > 10 mL in 1 PACKET
Marketing Start Date2009-08-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67386-211-65 [67386021165]

SABRIL POWDER, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA022006
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-08-21

Drug Details

Active Ingredients

IngredientStrength
VIGABATRIN50 mg/mL

OpenFDA Data

SPL SET ID:a88ac1b4-e2c9-45c0-b321-4785902172e3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 860898
  • 250820

    • Pharmacological Class

    • Anti-epileptic Agent [EPC]

    NDC Crossover Matching brand name "SABRIL" or generic name "Vigabatrin"

    NDCBrand NameGeneric Name
    67386-111SABRILvigabatrin
    67386-211SABRILvigabatrin
    0054-0652VigabatrinVigabatrin
    0574-0201VIGABATRINvigabatrin
    0574-0470VIGABATRINvigabatrin
    0591-3851VigabatrinVigabatrin
    0591-3955vigabatrinvigabatrin
    16729-521VigabatrinVigabatrin
    42799-950VigabatrinVigabatrin
    43598-651VigabatrinVigabatrin
    43598-697VigabatrinVigabatrin
    49884-358VIGABATRINvigabatrin
    59651-366VigabatrinVigabatrin
    59651-367VigabatrinVigabatrin
    64850-940Vigabatrinvigabatrin
    31722-009vigabatrin for oral solutionvigabatrin
    0054-0702Vigabatrin for oral solution USP, 500 mgVigabatrin
    0245-0556VIGADRONEvigabatrin

    Trademark Results [SABRIL]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SABRIL
    SABRIL
    88850165 not registered Live/Pending
    Lundbeck LLC
    2020-03-27
    SABRIL
    SABRIL
    86929029 not registered Live/Pending
    Lundbeck LLC
    2016-03-04
    SABRIL
    SABRIL
    78592387 not registered Dead/Abandoned
    Ovation Pharmaceuticals, Inc.
    2005-03-22
    SABRIL
    SABRIL
    73503513 1366276 Live/Registered
    MERRELL DOW PHARMACEUTICALS INC.
    1984-10-12
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