Gralise
These highlights do not include all the information needed to use GRALISE safely and effectively. See full prescribing information for GRALISE. GRALISE (gabapentin) tablets, for oral use Initial U.S. Approval: 1993
Approved
Approval ID
466273b1-c9fc-3930-c94b-aa11394d5140
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 1, 2023
Manufacturers
FDA
Almatica Pharma LLC
DUNS: 962454505
Products 6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
gabapentin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52427-806
Application NumberNDA022544
Product Classification
M
Marketing Category
C73594
G
Generic Name
gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 2, 2020
FDA Product Classification
INGREDIENTS (11)
GABAPENTINActive
Quantity: 600 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
gabapentin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52427-890
Application NumberNDA022544
Product Classification
M
Marketing Category
C73594
G
Generic Name
gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 2, 2020
FDA Product Classification
INGREDIENTS (10)
GABAPENTINActive
Quantity: 900 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE OXIDE 7000000Inactive
Code: G3MS6M810Y
Classification: IACT
gabapentin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52427-804
Application NumberNDA022544
Product Classification
M
Marketing Category
C73594
G
Generic Name
gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 2, 2020
FDA Product Classification
INGREDIENTS (10)
GABAPENTINActive
Quantity: 450 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE OXIDE 7000000Inactive
Code: G3MS6M810Y
Classification: IACT
gabapentin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52427-803
Application NumberNDA022544
Product Classification
M
Marketing Category
C73594
G
Generic Name
gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 2, 2020
FDA Product Classification
INGREDIENTS (11)
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
GABAPENTINActive
Quantity: 300 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
gabapentin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52427-850
Application NumberNDA022544
Product Classification
M
Marketing Category
C73594
G
Generic Name
gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 2, 2020
FDA Product Classification
INGREDIENTS (10)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE OXIDE 7000000Inactive
Code: G3MS6M810Y
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GABAPENTINActive
Quantity: 750 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
gabapentin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52427-815
Application NumberNDA022544
Product Classification
M
Marketing Category
C73594
G
Generic Name
gabapentin
Product Specifications
Effective DateOctober 2, 2020
FDA Product Classification