Felbamate

Product NDC
51525-0442
11-digit product format
515250442
Labeler code
51525
Product ID
51525-0442_525ae813-9695-47a8-8f75-9a3abadd3b50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
felbamate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Wallace Pharmaceuticals Inc.
Application
NDA020189
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2011-11-23
Marketing end
0000-00-00
Substance
FELBAMATE
Active strength
600 mg/5mL
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51525-0442-3ML - Milliliter51525-0442477366de-6980-4c71-b4bf-ab15b9251a2412012-07-24
51525-0442-8ML - Milliliter51525-04422de48056-bb9b-4444-bb9e-3726ac89e4fa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FELBAMATEACTIVE INGREDIENTX72RBB02N8FELBAMATE TABLET FELBAMATE SUSPENSION [WALLACE PHARMACEUTICALS INC.]2
FELBAMATEACTIVE MOIETYX72RBB02N8FELBAMATE TABLET FELBAMATE SUSPENSION [WALLACE PHARMACEUTICALS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51525-0442FELBAMATE TABLET FELBAMATE SUSPENSION [WALLACE PHARMACEUTICALS INC.]9Legacy NDC20250312_c0c15d60-1171-11e1-9be0-0002a5d5c51b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51525-0442-351525044203946 mL in 1 BOTTLE (51525-0442-3) 946 ml2011-11-230000-00-00NoNoCurrent
51525-0442-851525044208237 mL in 1 BOTTLE (51525-0442-8) 237 ml2011-11-230000-00-00NoNoCurrent