gabapentin
Gabapentin Tablets
Approved
Approval ID
8c0eeefc-ef5b-49f4-8411-ddbae312ed05
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 15, 2025
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 5
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 Code70771-1918
Application NumberANDA203934
Product Classification
M
Marketing Category
C73584
G
Generic Name
gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2025
FDA Product Classification
INGREDIENTS (9)
GABAPENTINActive
Quantity: 900 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
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
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
gabapentin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1916
Application NumberANDA203934
Product Classification
M
Marketing Category
C73584
G
Generic Name
gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2025
FDA Product Classification
INGREDIENTS (9)
GABAPENTINActive
Quantity: 450 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
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
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
gabapentin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1917
Application NumberANDA203934
Product Classification
M
Marketing Category
C73584
G
Generic Name
gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2025
FDA Product Classification
INGREDIENTS (9)
GABAPENTINActive
Quantity: 750 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
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
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
gabapentin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1861
Application NumberANDA203934
Product Classification
M
Marketing Category
C73584
G
Generic Name
gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2025
FDA Product Classification
INGREDIENTS (14)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
GABAPENTINActive
Quantity: 300 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
HYPROMELLOSE 2208 (100000 MPA.S)Inactive
Code: VM7F0B23ZI
Classification: IACT
POLYETHYLENE GLYCOL 7000000Inactive
Code: G3MS6M810Y
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
gabapentin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1862
Application NumberANDA203934
Product Classification
M
Marketing Category
C73584
G
Generic Name
gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2025
FDA Product Classification
INGREDIENTS (14)
GABAPENTINActive
Quantity: 600 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2208 (100000 MPA.S)Inactive
Code: VM7F0B23ZI
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 7000000Inactive
Code: G3MS6M810Y
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 9/15/2025
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1861-9 in bottle of 90 tablets
Gabapentin tablets, 300 mg
Rx only
90 tablets
gabapentin 300 mg
NDC 70771-1862-9 in bottle of 90 tablets
Gabapentin tablets, 600 mg
Rx only
90 tablets
gabapentin 600 mg
NDC 70771-1916-6 in bottle of 60 tablets
Gabapentin tablets, 450 mg
Rx only
60 tablets
NDC 70771-1917-6 in bottle of 60 tablets
Gabapentin tablets, 750 mg
Rx only
60 tablets
NDC 70771-1918-6 in bottle of 60 tablets
Gabapentin tablets, 900 mg
Rx only
60 tablets
