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 ID | 52427-806_cccddde4-ca61-3a25-fbba-c97fdcfd5f9e |
| NDC | 52427-806 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Gralise |
| Generic Name | Gabapentin |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-10-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA022544 |
| Labeler Name | Almatica Pharma LLC |
| 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 | 2022-12-31 |
| Marketing Start Date | 2020-10-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| 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 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GRALISE 88511419 not registered Live/Pending |
Assertio Therapeutics, Inc. 2019-07-12 |
![]() GRALISE 86982952 5312458 Live/Registered |
ASSERTIO THERAPEUTICS, INC. 2016-01-14 |
![]() GRALISE 86875330 not registered Dead/Abandoned |
ASSERTIO THERAPEUTICS, INC. 2016-01-14 |
![]() GRALISE 77934261 4132334 Live/Registered |
ASSERTIO THERAPEUTICS, INC. 2010-02-12 |