Gabapentin
These highlights do not include all the information needed to use GABAPENTIN ORAL SOLUTION safely and effectively. See full prescribing information for GABAPENTIN ORAL SOLUTION. GABAPENTIN oral solution Initial U.S. Approval: 1993
Approved
Approval ID
bfee67dc-d2b1-4a00-92d9-a42be3189c74
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 24, 2023
Manufacturers
FDA
Advagen Pharma Ltd
DUNS: 051627256
Products 1
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 Code72888-104
Application NumberANDA216492
Product Classification
M
Marketing Category
C73584
G
Generic Name
gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 24, 2023
FDA Product Classification
INGREDIENTS (10)
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
GABAPENTINActive
Quantity: 250 mg in 5 mL
Code: 6CW7F3G59X
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT