NDC 52427-803

Gralise

Gabapentin

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

Product ID52427-803_cccddde4-ca61-3a25-fbba-c97fdcfd5f9e
NDC52427-803
Product TypeHuman Prescription Drug
Proprietary NameGralise
Generic NameGabapentin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-10-01
Marketing CategoryNDA / NDA
Application NumberNDA022544
Labeler NameAlmatica Pharma LLC
Substance NameGABAPENTIN
Active Ingredient Strength300 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 52427-803-90

90 TABLET, FILM COATED in 1 BOTTLE (52427-803-90)
Marketing Start Date2020-10-01
NDC Exclude FlagN
Sample Package?N

Drug Details

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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