Gabapentin
These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN. GABAPENTIN oral solution Initial U.S. Approval: 1993
Approved
Approval ID
0b3a4009-42f3-c84f-e063-6294a90a8068
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2023
Manufacturers
FDA
BioComp Pharma, Inc.
DUNS: 829249718
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 Code44523-120
Application NumberANDA078974
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (6)
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GABAPENTINActive
Quantity: 250 mg in 5 mL
Code: 6CW7F3G59X
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT