FDA.reportPublic FDA data

Felbamate

Product NDC
65162-735
11-digit product format
651620735
Labeler code
65162
Product ID
65162-735_28bca98d-c89a-492a-a3e5-405098e33919
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felbamate
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA201680
Marketing category
ANDA
Marketing start
2011-09-16
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
65162-735-03Felbamate30 in 1 BOTTLETABLET3012
65162-735-09Felbamate90 in 1 BOTTLETABLET9012
65162-735-18Felbamate180 in 1 BOTTLETABLET18012
65162-735-27Felbamate270 in 1 BOTTLETABLET27012
65162-735-50Felbamate500 in 1 BOTTLETABLET50012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-735-03EA - Each65162-735d27c665c-ec48-4071-a004-d70ee85365f912012-07-24
65162-735-09EA - Each65162-7354f451aa6-03d6-4b10-a3c6-e2e4efe4973912012-07-24
65162-735-18EA - Each65162-7350741b0a4-e08c-4952-993d-a76a104a208712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FELBAMATEACTIVE INGREDIENTX72RBB02N8FELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
FELBAMATEACTIVE MOIETYX72RBB02N8FELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
FELBAMATEACTIVE INGREDIENTX72RBB02N8FELBAMATE TABLET [CARILION MATERIALS MANAGEMENT]2
FELBAMATEACTIVE MOIETYX72RBB02N8FELBAMATE TABLET [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFELBAMATE TABLET [CARILION MATERIALS MANAGEMENT]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FELBAMATE TABLET [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFELBAMATE TABLET [CARILION MATERIALS MANAGEMENT]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFELBAMATE TABLET [CARILION MATERIALS MANAGEMENT]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FELBAMATE TABLET [CARILION MATERIALS MANAGEMENT]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFELBAMATE TABLET [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FELBAMATE TABLET [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFELBAMATE TABLET [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-735FELBAMATE TABLET [AMNEAL PHARMACEUTICALS LLC]12Current NDC, Legacy NDC, 5 package rows20241012_aa3fd2c0-98d6-45f3-81b0-a902526214c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198358felbamate 400 MG Oral TabletPSNaa3fd2c0-98d6-45f3-81b0-a902526214c612
198359felbamate 600 MG Oral TabletPSNaa3fd2c0-98d6-45f3-81b0-a902526214c612
198358felbamate 400 MG Oral TabletSCDaa3fd2c0-98d6-45f3-81b0-a902526214c612
198359felbamate 600 MG Oral TabletSCDaa3fd2c0-98d6-45f3-81b0-a902526214c612
198358FELT 400 MG Oral TabletSYaa3fd2c0-98d6-45f3-81b0-a902526214c612
198359FELT 600 MG Oral TabletSYaa3fd2c0-98d6-45f3-81b0-a902526214c612
198359felbamate 600 MG Oral TabletPSNce919497-c2f3-4362-bfb7-cf4e82e10a5c3
198359felbamate 600 MG Oral TabletSCDce919497-c2f3-4362-bfb7-cf4e82e10a5c3
198359FELT 600 MG Oral TabletSYce919497-c2f3-4362-bfb7-cf4e82e10a5c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-735-036516207350330 TABLET in 1 BOTTLE (65162-735-03) 30 tablet2011-09-160000-00-00NoNoCurrent
65162-735-096516207350990 TABLET in 1 BOTTLE (65162-735-09) 90 tablet2011-09-160000-00-00NoNoCurrent
65162-735-1865162073518180 TABLET in 1 BOTTLE (65162-735-18) 180 tablet2011-09-160000-00-00NoNoCurrent
65162-735-2765162073527270 TABLET in 1 BOTTLE (65162-735-27) 270 tablet2011-09-160000-00-00NoNoCurrent
65162-735-5065162073550500 TABLET in 1 BOTTLE (65162-735-50) 500 tablet2011-09-160000-00-00NoNoCurrent