FDA.reportPublic FDA data

SABRIL

Product NDC
67386-111
11-digit product format
673860111
Labeler code
67386
Product ID
67386-111_09c27a1b-5916-4e16-a9a3-924099661be6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vigabatrin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lundbeck Pharmaceuticals LLC
Application
NDA020427
Marketing category
NDA
Marketing start
2009-08-21
Substance
VIGABATRIN
Active strength
500 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SABRIL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VIGABATRIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGR120KRT6K
Rxcui199521, 860895

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
096748f0-965a-4afd-a326-9f691a2861e8Product name120250224
9dea3de0-6f03-9477-9f83-4ffb0883e43fProduct name620240507
9a8c6108-e754-40ae-a629-36a466ae0079Product name820230314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67386-111-01SABRIL100 in 1 BOTTLETABLET, FILM COATED10040

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67386-111-01EA - Each67386-111edda328c-2665-419b-913a-9037fba3a43012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VIGABATRINACTIVE INGREDIENTGR120KRT6KSABRIL (VIGABATRIN) TABLET, FILM COATED [LUNDBECK LLC]11
VIGABATRINACTIVE MOIETYGR120KRT6KSABRIL (VIGABATRIN) TABLET, FILM COATED [LUNDBECK LLC]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USABRIL (VIGABATRIN) TABLET, FILM COATED [LUNDBECK LLC]11
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSABRIL (VIGABATRIN) TABLET, FILM COATED [LUNDBECK LLC]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SABRIL (VIGABATRIN) TABLET, FILM COATED [LUNDBECK LLC]11
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASABRIL (VIGABATRIN) TABLET, FILM COATED [LUNDBECK LLC]11
POVIDONESINACTIVE INGREDIENTFZ989GH94ESABRIL (VIGABATRIN) TABLET, FILM COATED [LUNDBECK LLC]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SABRIL (VIGABATRIN) TABLET, FILM COATED [LUNDBECK LLC]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSABRIL (VIGABATRIN) TABLET, FILM COATED [LUNDBECK LLC]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67386-111SABRIL (VIGABATRIN) TABLET, FILM COATED [LUNDBECK PHARMACEUTICALS LLC]36Current NDC, Legacy NDC, 1 package rows20241222_a5d389d2-d0e1-4395-a2a2-b552808e7f98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860895Sabril 500 MG Oral TabletPSNa5d389d2-d0e1-4395-a2a2-b552808e7f9840
199521vigabatrin 500 MG Oral TabletPSNa5d389d2-d0e1-4395-a2a2-b552808e7f9840
860895vigabatrin 500 MG Oral Tablet [Sabril]SBDa5d389d2-d0e1-4395-a2a2-b552808e7f9840
199521vigabatrin 500 MG Oral TabletSCDa5d389d2-d0e1-4395-a2a2-b552808e7f9840
860895Sabril 500 MG Oral TabletSYa5d389d2-d0e1-4395-a2a2-b552808e7f9840

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67386-111-0167386011101100 TABLET, FILM COATED in 1 BOTTLE (67386-111-01) 2009-08-210000-00-00NoNoCurrent