NDC 50436-1262

Gralise

Gabapentin

Gralise is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Unit Dose Services. The primary component is Gabapentin.

Product ID50436-1262_02926bb2-e906-467c-aae1-4dedaab2b7c3
NDC50436-1262
Product TypeHuman Prescription Drug
Proprietary NameGralise
Generic NameGabapentin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2011-01-28
Marketing CategoryNDA / NDA
Application NumberNDA022544
Labeler NameUnit Dose Services
Substance NameGABAPENTIN
Active Ingredient Strength600 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50436-1262-3

90 TABLET, FILM COATED in 1 BOTTLE (50436-1262-3)
Marketing Start Date2011-01-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50436-1262-3 [50436126203]

Gralise TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022544
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-01-28
Marketing End Date2017-12-31

Drug Details

Active Ingredients

IngredientStrength
GABAPENTIN600 mg/1

OpenFDA Data

SPL SET ID:11ba1b40-e30a-428e-9efa-3f40c9012ca0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1806382
  • 1115013

    • Pharmacological Class

    • Anti-epileptic Agent [EPC]
    • Decreased Central Nervous System Disorganized Electrical Activity [PE]

    NDC Crossover Matching brand name "Gralise" or generic name "Gabapentin"

    NDCBrand NameGeneric Name
    13913-004GraliseGralise
    13913-005GraliseGralise
    50436-1262GraliseGralise
    52427-803GraliseGralise
    52427-806GraliseGralise
    52427-815GraliseGralise
    0093-4443GabapentinGabapentin
    0093-4444GabapentinGabapentin
    0143-3991GabapentinGabapentin
    0143-3993GabapentinGabapentin
    0143-3994GabapentinGabapentin
    0143-9992GabapentinGabapentin
    0143-9993GabapentinGabapentin
    0143-9994GabapentinGabapentin
    0071-0401Neurontingabapentin
    0071-0513Neurontingabapentin
    0071-0803Neurontingabapentin
    0071-0805Neurontingabapentin
    0071-0806Neurontingabapentin
    0071-2012Neurontingabapentin

    Trademark Results [Gralise]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    GRALISE
    GRALISE
    88511419 not registered Live/Pending
    Assertio Therapeutics, Inc.
    2019-07-12
    GRALISE
    GRALISE
    86982952 5312458 Live/Registered
    ASSERTIO THERAPEUTICS, INC.
    2016-01-14
    GRALISE
    GRALISE
    86875330 not registered Dead/Abandoned
    ASSERTIO THERAPEUTICS, INC.
    2016-01-14
    GRALISE
    GRALISE
    77934261 4132334 Live/Registered
    ASSERTIO THERAPEUTICS, INC.
    2010-02-12
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