Home NDC 55289-561 Flurbiprofen
Product NDC 55289-561
11-digit product format 552890561
Labeler code 55289
Product ID 55289-561_8969cda4-e847-66f1-e053-2a95a90ae95d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name flurbiprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA074358
Marketing category ANDA
Marketing start 1994-06-20
Marketing end 0000-00-00
Substance FLURBIPROFEN
Active strength 100 mg/1
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 60 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074358-001 FLURBIPROFEN FLURBIPROFEN 50MG TABLET / ORAL 1994-06-20 A074358-002 FLURBIPROFEN FLURBIPROFEN 100MG TABLET / ORAL 1994-06-20
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A074358-001 FLURBIPROFEN 50MG TABLET / ORAL 1994-06-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074358-002 FLURBIPROFEN 100MG TABLET / ORAL 1994-06-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074358-001 FLURBIPROFEN 50MG TABLET / ORAL 1994-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074358-002 FLURBIPROFEN 100MG TABLET / ORAL 1994-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074358-001 FLURBIPROFEN 50MG TABLET / ORAL 1994-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074358-002 FLURBIPROFEN 100MG TABLET / ORAL 1994-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074358-001 FLURBIPROFEN 50MG TABLET / ORAL 1994-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074358-002 FLURBIPROFEN 100MG TABLET / ORAL 1994-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074358-001 FLURBIPROFEN 50MG TABLET / ORAL 1994-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074358-002 FLURBIPROFEN 100MG TABLET / ORAL 1994-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074358-001 FLURBIPROFEN 50MG TABLET / ORAL 1994-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074358-002 FLURBIPROFEN 100MG TABLET / ORAL 1994-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074358-001 FLURBIPROFEN 50MG TABLET / ORAL 1994-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074358-002 FLURBIPROFEN 100MG TABLET / ORAL 1994-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074358-001 FLURBIPROFEN 50MG TABLET / ORAL 1994-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074358-002 FLURBIPROFEN 100MG TABLET / ORAL 1994-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074358-001 FLURBIPROFEN 50MG TABLET / ORAL 1994-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074358-002 FLURBIPROFEN 100MG TABLET / ORAL 1994-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074358-001 FLURBIPROFEN 50MG TABLET / ORAL 1994-06-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074358-002 FLURBIPROFEN 100MG TABLET / ORAL 1994-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074358-001 FLURBIPROFEN 50MG TABLET / ORAL 1994-06-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074358-002 FLURBIPROFEN 100MG TABLET / ORAL 1994-06-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074358-001 FLURBIPROFEN 50MG TABLET / ORAL 1994-06-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074358-002 FLURBIPROFEN 100MG TABLET / ORAL 1994-06-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074358-001 FLURBIPROFEN 50MG TABLET / ORAL 1994-06-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074358-002 FLURBIPROFEN 100MG TABLET / ORAL 1994-06-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074358-001 FLURBIPROFEN 50MG TABLET / ORAL 1994-06-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074358-002 FLURBIPROFEN 100MG TABLET / ORAL 1994-06-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074358-001 FLURBIPROFEN 50MG TABLET / ORAL 1994-06-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074358-002 FLURBIPROFEN 100MG TABLET / ORAL 1994-06-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074358-001 FLURBIPROFEN 50MG TABLET / ORAL 1994-06-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074358-002 FLURBIPROFEN 100MG TABLET / ORAL 1994-06-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074358-001 FLURBIPROFEN 50MG TABLET / ORAL 1994-06-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074358-002 FLURBIPROFEN 100MG TABLET / ORAL 1994-06-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074358-001 FLURBIPROFEN 50MG TABLET / ORAL 1994-06-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074358-002 FLURBIPROFEN 100MG TABLET / ORAL 1994-06-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074358-001 FLURBIPROFEN 50MG TABLET / ORAL 1994-06-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074358-002 FLURBIPROFEN 100MG TABLET / ORAL AB RS 1994-06-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074358-001 FLURBIPROFEN 50MG TABLET / ORAL 1994-06-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074358-002 FLURBIPROFEN 100MG TABLET / ORAL 1994-06-20 bb7c543d1eb4…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLURBIPROFEN ACTIVE INGREDIENT 5GRO578KLP FLURBIPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 FLURBIPROFEN ACTIVE MOIETY 5GRO578KLP FLURBIPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK FLURBIPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FLURBIPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FLURBIPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT FLURBIPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 FLURBIPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FLURBIPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLURBIPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE FLURBIPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A FLURBIPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FLURBIPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J FLURBIPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FLURBIPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 FLURBIPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3