Home NDC 64950-218 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 42 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 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…2022-10-28 04:53 UTC 2022-10 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074431-001 FLURBIPROFEN 100MG TABLET / ORAL RS 1995-05-31 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Flurbiprofen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLURBIPROFEN 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5GRO578KLP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197724 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64950-218-10 Flurbiprofen 100 in 1 BOTTLE TABLET 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64950-218 FLURBIPROFEN TABLET [GENUS LIFESCIENCES] 1 Current NDC, 1 package rows 20241122_4670cf21-eb0e-4f5a-ab22-41af85733525.zip
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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Flurbiprofen FLURBIPROFEN Genus Lifesciences 4670cf21-eb0e-4f5a-ab22-41af85733525 2026-02-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074431 application number: ANDA074431 ndc (product): 64950-218 LURBIRO FLURBIPROFEN IPG Pharmaceuticals, Inc. 7ebf7427-eaae-4035-a6b2-0ea6381e8763 2025-07-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074431 application number: ANDA074431 Flurbiprofen FLURBIPROFEN NuCare Pharmaceuticals,Inc. 6c6a0daa-de1b-5455-e053-2991aa0a4cf8 2024-06-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074431 application number: ANDA074431
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 64950-218-10 64950021810 100 TABLET in 1 BOTTLE (64950-218-10) 100 tablet 2024-11-01 No No Current