SABRIL
These highlights do not include all the information needed to use SABRIL safely and effectively. See full prescribing information for SABRIL . SABRIL ( vigabatrin ) t ablet s , for oral use SABRIL ( vigabatrin ) for o ral s olution Initial U.S. Approval: 2009
a5d389d2-d0e1-4395-a2a2-b552808e7f98
HUMAN PRESCRIPTION DRUG LABEL
Sep 30, 2025
Lundbeck Pharmaceuticals LLC
DUNS: 009582068
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
vigabatrin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (8)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL****
NDC 67386-111-01
Sabril®
(vigabatrin) Tablets
500 mg
DISPENSE THE ENCLOSED MEDICATION
GUIDE WITH EACH PRESCTIPTION.
****Rx only
100 Tablets
DESCRIPTION SECTION
11****DESCRIPTION
SABRIL (vigabatrin) is an oral antiepileptic drug and is available as white film-coated 500 mg tablets and as a white to off-white granular powder for oral solution in packets of 500 mg.
The chemical name of vigabatrin, a racemate consisting of two enantiomers, is (±) 4-amino-5-hexenoic acid. The molecular formula is C6H11NO2 and the molecular weight is 129.16. It has the following structural formula:
Vigabatrin is a white to off-white powder which is freely soluble in water, slightly soluble in methyl alcohol, very slightly soluble in ethyl alcohol and chloroform, and insoluble in toluene and hexane. The pH of a 1% aqueous solution is about 6.9. The n-octanol/water partition coefficient of vigabatrin is about 0.011 (log P=-1.96) at physiologic pH. Vigabatrin melts with decomposition in a 3-degree range within the temperature interval of 171ºC to 176ºC. The dissociation constants (pKa) of vigabatrin are 4 and 9.7 at room temperature (25ºC).
Each SABRIL tablet contains 500 mg of vigabatrin. The inactive ingredients are hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycols, povidone, sodium starch glycolate, and titanium dioxide.
SABRIL for oral solution is available as a white to off-white granular powder. Each packet contains 500 mg of vigabatrin. The inactive ingredient is povidone.