FDA.reportPublic FDA data

Felbamate

Product NDC
16714-775
11-digit product format
167140775
Labeler code
16714
Product ID
16714-775_c3010d7b-f928-464e-af7c-ca45a5320a20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Felbamate
Dosage form
SUSPENSION
Route
ORAL
Labeler
NORTHSTAR RX LLC
Application
ANDA206314
Marketing category
ANDA
Marketing start
2018-04-10
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-775-01Felbamate237 mL in 1 BOTTLESUSPENSION2371
16714-775-02Felbamate473 mL in 1 BOTTLESUSPENSION4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-775-01ML - Milliliter16714-7756fd1ffff-77a4-48c9-873d-c65c9bb6f6cc12018-07-03
16714-775-02ML - Milliliter16714-7755afacd26-8bf2-45fb-a644-a214ce6a178012018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-775FELBAMATE SUSPENSION [NORTHSTAR RX LLC]1Current NDC, Legacy NDC, 2 package rows20180516_556de35d-3b98-48d3-a670-50e9d93437a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310285felbamate 600 MG in 5 mL Oral SuspensionPSN556de35d-3b98-48d3-a670-50e9d93437a41
310285felbamate 120 MG/ML Oral SuspensionSCD556de35d-3b98-48d3-a670-50e9d93437a41
310285felbamate 600 MG per 5 ML Oral SuspensionSY556de35d-3b98-48d3-a670-50e9d93437a41
310285FELT 120 MG/ML Oral SuspensionSY556de35d-3b98-48d3-a670-50e9d93437a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-775-0116714077501237 mL in 1 BOTTLE (16714-775-01) 237 ml2018-04-100000-00-00NoNoCurrent
16714-775-0216714077502473 mL in 1 BOTTLE (16714-775-02) 473 ml2018-04-100000-00-00NoNoCurrent