Home NDC 68071-4436 Flurbiprofen
Product NDC 68071-4436
11-digit product format 680714436
Labeler code 68071
Product ID 68071-4436_1a8c403f-badb-36b1-e063-6394a90a18d5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Flurbiprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA074431
Marketing category ANDA
Marketing start 1995-06-02
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 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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68071-4436-4 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68071-4436-4 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68071-4436-4 1332a3947898…d4bfe170f9cd…
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 2026-12-31 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-4436-4 Flurbiprofen 14 in 1 BOTTLE TABLET, FILM COATED 14 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-4436 FLURBIPROFEN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] 6 Current NDC, Legacy NDC, 1 package rows 20240612_6c6a0daa-de1b-5455-e053-2991aa0a4cf8.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 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 ndc (product): 68071-4436
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68071-4436-4 68071443604 14 TABLET, FILM COATED in 1 BOTTLE (68071-4436-4) 2018-05-17 0000-00-00 No No Current