Flurbiprofen

Product NDC
43063-992
11-digit product format
430630992
Labeler code
43063
Product ID
43063-992_e3b3b7fc-f8fd-9d7f-e053-2a95a90a3121
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flurbiprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA074431
Marketing category
ANDA
Marketing start
1995-06-02
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-992-15EA - Each43063-992c8a0ceae-4671-45e0-8f87-184fdc2d5a6b12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-992FLURBIPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]16Legacy NDC20241019_0585c6bf-e401-4112-b4b4-c8d56c3b0f1c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-992-154306309921515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-992-15) 2019-06-180000-00-00NoNoCurrent