FDA.reportPublic FDA data

Felbamate

Product NDC
72578-057
11-digit product format
725780057
Labeler code
72578
Product ID
72578-057_e719dd84-3938-4531-871c-4433fec8f4a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felbamate
Dosage form
TABLET
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA208970
Marketing category
ANDA
Marketing start
2020-03-03
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Felbamate
Listing expiration
2027-12-31

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
72578-057-01Felbamate100 in 1 BOTTLETABLET1003
72578-057-05Felbamate500 in 1 BOTTLETABLET5003
72578-057-06Felbamate30 in 1 BOTTLETABLET303
72578-057-16Felbamate90 in 1 BOTTLETABLET903
72578-057-28Felbamate180 in 1 BOTTLETABLET1803
72578-057-30Felbamate10 in 1 BLISTER PACKTABLET103
72578-057-77Felbamate10 in 1 CARTONTABLET103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-057-01EA - Each72578-057213710cd-f7b1-47fa-ac31-2e27ac77b1ed12021-03-02
72578-057-16EA - Each72578-057bbb59c29-22bd-4e8a-8028-371fec34282d12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-057FELBAMATE TABLET [VIONA PHARMACEUTICALS INC]2Current NDC, Legacy NDC, 7 package rows20221122_96f4357c-720c-4651-b638-7b1181531dc5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198358felbamate 400 MG Oral TabletPSN96f4357c-720c-4651-b638-7b1181531dc53
198359felbamate 600 MG Oral TabletPSN96f4357c-720c-4651-b638-7b1181531dc53
198358felbamate 400 MG Oral TabletSCD96f4357c-720c-4651-b638-7b1181531dc53
198359felbamate 600 MG Oral TabletSCD96f4357c-720c-4651-b638-7b1181531dc53
198358FELT 400 MG Oral TabletSY96f4357c-720c-4651-b638-7b1181531dc53
198359FELT 600 MG Oral TabletSY96f4357c-720c-4651-b638-7b1181531dc53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72578-057-0172578005701100 TABLET in 1 BOTTLE (72578-057-01) 100 tablet2020-03-030000-00-00NoNoCurrent
72578-057-0572578005705500 TABLET in 1 BOTTLE (72578-057-05) 500 tablet2020-03-030000-00-00NoNoCurrent
72578-057-067257800570630 TABLET in 1 BOTTLE (72578-057-06) 30 tablet2020-03-030000-00-00NoNoCurrent
72578-057-167257800571690 TABLET in 1 BOTTLE (72578-057-16) 90 tablet2020-03-030000-00-00NoNoCurrent
72578-057-2872578005728180 TABLET in 1 BOTTLE (72578-057-28) 180 tablet2020-03-030000-00-00NoNoCurrent
72578-057-307257800573010 in 1 BLISTER PACKHistorical
72578-057-777257800577710 BLISTER PACK in 1 CARTON (72578-057-77) / 10 TABLET in 1 BLISTER PACK (72578-057-30) 10 blister pack2020-03-030000-00-00NoNoCurrent