Home NDC 71085-082 LURBIRO
Product NDC 71085-082
11-digit product format 710850082
Labeler code 71085
Product ID 71085-082_5d1c694f-f678-baf4-e063-6394a90aa30d
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074431-001 FLURBIPROFEN FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31
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 2 · 44 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 2026-10-15 13:18:30 2026-09 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 c2088c7a36db…2026-09-14 22:38:34 2026-08 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL AB 1995-05-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL AB 1995-05-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL AB 1995-05-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL AB 1995-05-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 3a93d1ddd44b…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base LURBIRO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLURBIPROFEN 100 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71085-082-30 LURBIRO 30 in 1 BOTTLE TABLET 30 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71085-082-30 71085008230 30 TABLET in 1 BOTTLE (71085-082-30) 30 tablet 2025-08-01 No No Current