Felbamate

Product NDC
72162-1770
11-digit product format
721621770
Labeler code
72162
Product ID
72162-1770_87d6eea6-03a0-401f-a858-6d458cc5c022
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
400 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
FELBAMATE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX72RBB02N8
Rxcui198358

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
72162-1770-1Felbamate100 in 1 BOTTLETABLET100102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1770-1EA - Each72162-1770592fbaf2-7273-40ab-b1df-6082d77626cf12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1770FELBAMATE TABLET [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20250403_d6eaf094-09e2-480c-bea9-7a2768aad884.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198358felbamate 400 MG Oral TabletPSNd6eaf094-09e2-480c-bea9-7a2768aad884102
198358felbamate 400 MG Oral TabletSCDd6eaf094-09e2-480c-bea9-7a2768aad884102
198358FELT 400 MG Oral TabletSYd6eaf094-09e2-480c-bea9-7a2768aad884102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1770-172162177001100 TABLET in 1 BOTTLE (72162-1770-1) 100 tablet2026-03-25NoNoHistorical