Felbamate

Product NDC
63629-1944
11-digit product format
636291944
Labeler code
63629
Product ID
63629-1944_27426bc1-4084-4e2f-a06f-05830677d2a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felbamate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202284
Marketing category
ANDA
Marketing start
2018-09-04
Substance
FELBAMATE
Active strength
600 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FELBAMATE600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX72RBB02N8
Rxcui198359

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b0edd10c-1754-6637-302d-00e8fb86191cProduct name520190828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1944-1Felbamate100 in 1 BOTTLETABLET100104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1944-1EA - Each63629-19449696070e-1525-4980-9e4e-e69c56794f7b12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1944FELBAMATE TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20250321_3170233c-0452-4150-9e4c-dfffcde7424e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198359felbamate 600 MG Oral TabletPSN3170233c-0452-4150-9e4c-dfffcde7424e104
198359felbamate 600 MG Oral TabletSCD3170233c-0452-4150-9e4c-dfffcde7424e104
198359FELT 600 MG Oral TabletSY3170233c-0452-4150-9e4c-dfffcde7424e104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1944-163629194401100 TABLET in 1 BOTTLE (63629-1944-1) 100 tablet2021-01-190000-00-00NoNoCurrent