GABAPENTIN
These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral useInitial U.S. Approval: 1993
Approved
Approval ID
7fcce531-bf7c-43b6-bea9-8f0602842c53
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 1, 2025
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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 Code82804-193
Application NumberANDA214957
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gabapentin
Product Specifications
Route of AdministrationORAL
Effective DateApril 1, 2025
FDA Product Classification
INGREDIENTS (8)
GABAPENTINActive
Quantity: 600 mg in 1 1
Code: 6CW7F3G59X
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 2/1/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 2/1/2025
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 2/1/2025
WARNINGS AND PRECAUTIONS SECTION
LOINC: 43685-7Updated: 2/1/2025
ADVERSE REACTIONS SECTION
LOINC: 34084-4Updated: 2/1/2025
DRUG INTERACTIONS SECTION
LOINC: 34073-7Updated: 2/1/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 2/1/2025
DOSAGE FORMS & STRENGTHS SECTION
LOINC: 43678-2Updated: 2/1/2025
USE IN SPECIFIC POPULATIONS SECTION
LOINC: 43684-0Updated: 2/1/2025
DRUG ABUSE AND DEPENDENCE SECTION
LOINC: 42227-9Updated: 2/1/2025
OVERDOSAGE SECTION
LOINC: 34088-5Updated: 2/1/2025
DESCRIPTION SECTION
LOINC: 34089-3Updated: 2/1/2025
CLINICAL PHARMACOLOGY SECTION
LOINC: 34090-1Updated: 2/1/2025
NONCLINICAL TOXICOLOGY SECTION
LOINC: 43680-8Updated: 2/1/2025
CLINICAL STUDIES SECTION
LOINC: 34092-7Updated: 2/1/2025
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 2/1/2025
INFORMATION FOR PATIENTS SECTION
LOINC: 34076-0Updated: 2/1/2025
SPL MEDGUIDE SECTION
LOINC: 42231-1Updated: 2/1/2025