GABAPENTIN
These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
Approved
Approval ID
618c948d-deee-44e2-98f0-e5232171dd50
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 22, 2023
Manufacturers
FDA
XLCare Pharmaceuticals, Inc.
DUNS: 080991142
Products 3
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 Code72865-252
Application NumberANDA214956
Product Classification
M
Marketing Category
C73584
G
Generic Name
gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 21, 2023
FDA Product Classification
INGREDIENTS (14)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
GABAPENTINActive
Quantity: 100 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
gabapentin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72865-254
Application NumberANDA214956
Product Classification
M
Marketing Category
C73584
G
Generic Name
gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 21, 2023
FDA Product Classification
INGREDIENTS (16)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
GABAPENTINActive
Quantity: 400 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
gabapentin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72865-253
Application NumberANDA214956
Product Classification
M
Marketing Category
C73584
G
Generic Name
gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 21, 2023
FDA Product Classification
INGREDIENTS (16)
GABAPENTINActive
Quantity: 300 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT