LURBIRO

Product NDC
71085-082
11-digit product format
710850082
Labeler code
71085
Product ID
71085-082_3b2b98e9-9358-52c6-e063-6394a90a3758
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flurbiprofen
Dosage form
TABLET
Route
ORAL
Labeler
IPG Pharmaceuticals, Inc.
Application
ANDA074431
Marketing category
ANDA
Marketing start
2025-08-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LURBIRO
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLURBIPROFEN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5GRO578KLP
Rxcui197724, 2720355

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
71085-082-30LURBIRO30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71085-082-30EA - Each71085-0825aaa341f-4bba-4343-8d40-b30fe5da80c112025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197724flurbiprofen 100 MG Oral TabletPSN7ebf7427-eaae-4035-a6b2-0ea6381e87631
2720355LURBIRO 100 MG Oral TabletPSN7ebf7427-eaae-4035-a6b2-0ea6381e87631
2720355flurbiprofen 100 MG Oral Tablet [Lurbiro]SBD7ebf7427-eaae-4035-a6b2-0ea6381e87631
197724flurbiprofen 100 MG Oral TabletSCD7ebf7427-eaae-4035-a6b2-0ea6381e87631
2720355Lurbiro 100 MG Oral TabletSY7ebf7427-eaae-4035-a6b2-0ea6381e87631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71085-082-307108500823030 TABLET in 1 BOTTLE (71085-082-30) 30 tablet2025-08-01NoNoHistorical