Flurbiprofen

Product NDC: 45865-918
11-digit product format: 458650918
Labeler code: 45865
Product ID: 45865-918_9ab45dce-088d-7b93-e053-2a95a90a9a78
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Flurbiprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: medsource pharmaceuticals
Application: ANDA074431
Marketing category: ANDA
Marketing start: 1995-06-02
Marketing end: 0000-00-00
Substance: FLURBIPROFEN
Active strength: 100 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	45865-918		D	Discontinued by firm	2026-08-17
excluded package	package	45865-918	45865-918-30	D	Discontinued by firm	2026-08-17
excluded package	package	45865-918	45865-918-60	D	Discontinued by firm	2026-08-17
excluded package	package	45865-918	45865-918-90	D	Discontinued by firm	2026-08-17

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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A074431-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A074431-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074431-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074431-001	AB	1	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
45865-918-30	2026-01-29	These highlights do not include all the information needed to use FLURBIPROFEN TABLETS safely and effectively. See full prescribing information for FLURBIPROFEN TABLETS. FLURBIPROFEN tablets, for oral use Initial U.S. Approval: 1988
45865-918-60	2026-01-29	These highlights do not include all the information needed to use FLURBIPROFEN TABLETS safely and effectively. See full prescribing information for FLURBIPROFEN TABLETS. FLURBIPROFEN tablets, for oral use Initial U.S. Approval: 1988
45865-918-90	2026-01-29	These highlights do not include all the information needed to use FLURBIPROFEN TABLETS safely and effectively. See full prescribing information for FLURBIPROFEN TABLETS. FLURBIPROFEN tablets, for oral use Initial U.S. Approval: 1988
45865-918-30	2024-02-29	These highlights do not include all the information needed to use FLURBIPROFEN TABLETS safely and effectively. See full prescribing information for FLURBIPROFEN TABLETS. FLURBIPROFEN tablets, for oral use Initial U.S. Approval: 1988
45865-918-60	2024-02-29	These highlights do not include all the information needed to use FLURBIPROFEN TABLETS safely and effectively. See full prescribing information for FLURBIPROFEN TABLETS. FLURBIPROFEN tablets, for oral use Initial U.S. Approval: 1988
45865-918-90	2024-02-29	These highlights do not include all the information needed to use FLURBIPROFEN TABLETS safely and effectively. See full prescribing information for FLURBIPROFEN TABLETS. FLURBIPROFEN tablets, for oral use Initial U.S. Approval: 1988
45865-918-30	2023-01-30	These highlights do not include all the information needed to use FLURBIPROFEN TABLETS safely and effectively. See full prescribing information for FLURBIPROFEN TABLETS. FLURBIPROFEN tablets, for oral use Initial U.S. Approval: 1988
45865-918-60	2023-01-30	These highlights do not include all the information needed to use FLURBIPROFEN TABLETS safely and effectively. See full prescribing information for FLURBIPROFEN TABLETS. FLURBIPROFEN tablets, for oral use Initial U.S. Approval: 1988
45865-918-90	2023-01-30	These highlights do not include all the information needed to use FLURBIPROFEN TABLETS safely and effectively. See full prescribing information for FLURBIPROFEN TABLETS. FLURBIPROFEN tablets, for oral use Initial U.S. Approval: 1988

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-918	FLURBIPROFEN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	3	Legacy NDC	20240302_7df104c9-edb9-6aaf-e053-2a91aa0aefad.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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5GRO578KLP	FLURBIPROFEN	5104-49-4	FLURBIPROFEN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-918-30	45865091830	30 TABLET, FILM COATED in 1 BOTTLE (45865-918-30)	2018-06-01	0000-00-00	No	No	Current
45865-918-60	45865091860	60 TABLET, FILM COATED in 1 BOTTLE (45865-918-60)	2018-06-01	0000-00-00	No	No	Current
45865-918-90	45865091890	90 TABLET, FILM COATED in 1 BOTTLE (45865-918-90)	2018-06-01	0000-00-00	No	No	Current