NDC 13913-005

Gralise

Gabapentin

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

• Product ID: 13913-005_15b124c8-345a-3a45-2c20-fbe258fb82b3
• NDC: 13913-005
• Product Type: Human Prescription Drug
• Proprietary Name: Gralise
• Generic Name: Gabapentin
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2011-01-28
• Marketing Category: NDA / NDA
• Application Number: NDA022544
• Labeler Name: Assertio Therapeutics, Inc.
• Substance Name: GABAPENTIN
• Active Ingredient Strength: 600 mg/1
• Pharm Classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 13913-005-19

90 TABLET, FILM COATED in 1 BOTTLE (13913-005-19)

• Marketing Start Date: 2011-01-28
• Marketing End Date: 2023-09-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 13913-005-19 [13913000519]

Gralise TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022544
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-01-28

Drug Details

Active Ingredients

Ingredient	Strength
GABAPENTIN	600 mg/1

OpenFDA Data

• SPL SET ID: 7d12b4e9-ed44-43c0-9e46-f6c195300f03
• Manufacturer:
  • Depomed, Inc.
• UNII:
  • 6CW7F3G59X
• RxNorm Concept Unique ID - RxCUI:
  • 1115015
  • 1115016
  • 1115012
  • 1115013
  • 1806382
  • 1806380
• UPC Code:
  • 0313913004196
  • 0313913004912
  • 0313913005193

Pharmacological Class

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

Medicade Reported Pricing

13913000519 GRALISE ER 600 MG TABLET

Pricing Unit: EA | Drug Type:

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

NDC	Brand Name	Generic Name
13913-004	Gralise	Gralise
13913-005	Gralise	Gralise
50436-1262	Gralise	Gralise
52427-803	Gralise	Gralise
52427-806	Gralise	Gralise
52427-815	Gralise	Gralise
0093-4443	Gabapentin	Gabapentin
0093-4444	Gabapentin	Gabapentin
0143-3991	Gabapentin	Gabapentin
0143-3993	Gabapentin	Gabapentin
0143-3994	Gabapentin	Gabapentin
0143-9992	Gabapentin	Gabapentin
0143-9993	Gabapentin	Gabapentin
0143-9994	Gabapentin	Gabapentin
0071-0401	Neurontin	gabapentin
0071-0513	Neurontin	gabapentin
0071-0803	Neurontin	gabapentin
0071-0805	Neurontin	gabapentin
0071-0806	Neurontin	gabapentin
0071-2012	Neurontin	gabapentin