Flurbiprofen

Product NDC
64950-218
11-digit product format
649500218
Labeler code
64950
Product ID
64950-218_d3fa269f-43c4-4862-b4d2-ec5b04d050c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flurbiprofen
Dosage form
TABLET
Route
ORAL
Labeler
Genus Lifesciences
Application
ANDA074431
Marketing category
ANDA
Marketing start
2024-11-01
Substance
FLURBIPROFEN
Active strength
100 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLURBIPROFEN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5GRO578KLP
Rxcui197724

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4de25cad-9156-ffae-eb2b-85736b333948Product name220201015
4d57173b-5512-6c00-533c-5ed2a40fc5b8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64950-218-10Flurbiprofen100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64950-218-10EA - Each64950-21801f88f56-526f-49b8-950e-3acb4363359012024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64950-218FLURBIPROFEN TABLET [GENUS LIFESCIENCES]1Current NDC, 1 package rows20241122_4670cf21-eb0e-4f5a-ab22-41af85733525.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197724flurbiprofen 100 MG Oral TabletPSN4670cf21-eb0e-4f5a-ab22-41af857335252
197724flurbiprofen 100 MG Oral TabletSCD4670cf21-eb0e-4f5a-ab22-41af857335252

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64950-218-1064950021810100 TABLET in 1 BOTTLE (64950-218-10) 100 tablet2024-11-01NoNoHistorical