FDA.reportPublic FDA data

Felbamate

Product NDC
51672-4186
11-digit product format
516724186
Labeler code
51672
Product ID
51672-4186_0c6d8e37-6982-22d4-e063-6294a90a4f6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felbamate
Dosage form
TABLET
Route
ORAL
Labeler
Taro Pharmaceuticals U.S.A., inc.
Application
ANDA207093
Marketing category
ANDA
Marketing start
2017-04-20
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
Rxcui198358, 198359

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
51672-4186-1Felbamate100 in 1 BOTTLETABLET1006
51672-4186-5Felbamate90 in 1 BOTTLETABLET906
51672-4186-6Felbamate30 in 1 BOTTLETABLET306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4186-1EA - Each51672-41861e71b93d-2881-4fef-b900-7f2c1d69a16d12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4186FELBAMATE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]6Current NDC, Legacy NDC, 3 package rows20231216_f2edb3ed-da20-4093-88ea-00fe781e47e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198358felbamate 400 MG Oral TabletPSNf2edb3ed-da20-4093-88ea-00fe781e47e06
198359felbamate 600 MG Oral TabletPSNf2edb3ed-da20-4093-88ea-00fe781e47e06
198358felbamate 400 MG Oral TabletSCDf2edb3ed-da20-4093-88ea-00fe781e47e06
198359felbamate 600 MG Oral TabletSCDf2edb3ed-da20-4093-88ea-00fe781e47e06
198358FELT 400 MG Oral TabletSYf2edb3ed-da20-4093-88ea-00fe781e47e06
198359FELT 600 MG Oral TabletSYf2edb3ed-da20-4093-88ea-00fe781e47e06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4186-151672418601100 TABLET in 1 BOTTLE (51672-4186-1) 100 tablet2017-04-200000-00-00NoNoCurrent
51672-4186-55167241860590 TABLET in 1 BOTTLE (51672-4186-5) 90 tablet2023-12-15NoNoHistorical
51672-4186-65167241860630 TABLET in 1 BOTTLE (51672-4186-6) 30 tablet2017-04-200000-00-00NoNoCurrent