FDA.reportPublic FDA data

Felbamate

Product NDC
51672-4172
11-digit product format
516724172
Labeler code
51672
Product ID
51672-4172_ff558824-b008-4b94-8aa5-d7818bc27a4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felbamate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA206314
Marketing category
ANDA
Marketing start
2017-06-16
Substance
FELBAMATE
Active strength
600 mg/5mL
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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX72RBB02N8
Rxcui310285

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b0edd10c-1754-6637-302d-00e8fb86191cProduct name520190828
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4172-1Felbamate237 mL in 1 BOTTLESUSPENSION2373
51672-4172-9Felbamate473 mL in 1 BOTTLESUSPENSION4733

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4172-1ML - Milliliter51672-4172b9e234bf-bcb9-4c4b-a0e0-f5f48955ad0812017-07-07
51672-4172-9ML - Milliliter51672-41722c09f0b8-bb48-4a6d-8f69-7eebafb066ed12017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4172FELBAMATE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, Legacy NDC, 2 package rows20170623_0afffb17-e6ac-4bea-a90e-7ef3c8150290.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310285felbamate 600 MG in 5 mL Oral SuspensionPSN0afffb17-e6ac-4bea-a90e-7ef3c81502903
310285felbamate 120 MG/ML Oral SuspensionSCD0afffb17-e6ac-4bea-a90e-7ef3c81502903
310285felbamate 600 MG per 5 ML Oral SuspensionSY0afffb17-e6ac-4bea-a90e-7ef3c81502903
310285FELT 120 MG/ML Oral SuspensionSY0afffb17-e6ac-4bea-a90e-7ef3c81502903

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4172-151672417201237 mL in 1 BOTTLE (51672-4172-1) 237 ml2017-06-160000-00-00NoNoCurrent
51672-4172-951672417209473 mL in 1 BOTTLE (51672-4172-9) 473 ml2017-06-160000-00-00NoNoCurrent