Felbamate

Product NDC
68151-4474
11-digit product format
681514474
Labeler code
68151
Product ID
68151-4474_a2ac138d-ff4d-42fd-ac27-c19ac6c31d98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felbamate
Dosage form
TABLET
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA201680
Marketing category
ANDA
Marketing start
2011-09-16
Marketing end
0000-00-00
Substance
FELBAMATE
Active strength
600 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-4474-02020-01-31C16284748780-19d75b9cf-f485-f424-e053-dadaa90a57ceFELBAMATE TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-4474-0Felbamate1 in 1 PACKAGETABLET13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
68151-4474FELBAMATE TABLET [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20160806_ce919497-c2f3-4362-bfb7-cf4e82e10a5c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionStatus
68151-4474-0681514474001 in 1 PACKAGEHistorical