FDA.reportPublic FDA data

Felbamate

Product NDC
70954-051
11-digit product format
709540051
Labeler code
70954
Product ID
70954-051_ca7073d4-4e4c-48b5-892a-2c33fa54062d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felbamate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Novitium Pharma LLC
Application
ANDA211333
Marketing category
ANDA
Marketing start
2022-07-15
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
b0edd10c-1754-6637-302d-00e8fb86191cProduct name520190828
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70954-051-10Felbamate237 mL in 1 BOTTLESUSPENSION2372
70954-051-20Felbamate473 mL in 1 BOTTLESUSPENSION4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-051-10ML - Milliliter70954-051e84b886c-3b0b-4258-a80c-f82cf69e640412022-08-04
70954-051-20ML - Milliliter70954-051b409bfe0-2d05-4803-99cf-f86bcb2beec712022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-051FELBAMATE SUSPENSION [NOVITIUM PHARMA LLC]2Current NDC, Legacy NDC, 2 package rows20221021_81c8a2e1-732c-4467-84e9-53fef1655ee2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310285felbamate 600 MG in 5 mL Oral SuspensionPSN81c8a2e1-732c-4467-84e9-53fef1655ee22
310285felbamate 120 MG/ML Oral SuspensionSCD81c8a2e1-732c-4467-84e9-53fef1655ee22
310285felbamate 600 MG per 5 ML Oral SuspensionSY81c8a2e1-732c-4467-84e9-53fef1655ee22
310285FELT 120 MG/ML Oral SuspensionSY81c8a2e1-732c-4467-84e9-53fef1655ee22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-051-1070954005110237 mL in 1 BOTTLE (70954-051-10) 237 ml2022-07-150000-00-00NoNoCurrent
70954-051-2070954005120473 mL in 1 BOTTLE (70954-051-20) 473 ml2022-07-150000-00-00NoNoCurrent