Flurbiprofen

Product NDC: 63629-8338
Requested package NDC: 63629-8338-1
11-digit product format: 636298338
Labeler code: 63629
Product ID: 63629-8338_b018b566-3288-430e-b430-2a2d37f8da9d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Flurbiprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63629-8338	63629-8338-1	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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4de25cad-9156-ffae-eb2b-85736b333948	Product name	2	20201015
4d57173b-5512-6c00-533c-5ed2a40fc5b8	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-8338-1	Flurbiprofen	30 in 1 BOTTLE	TABLET, FILM COATED	30		1004
63629-8338-2	Flurbiprofen	60 in 1 BOTTLE	TABLET, FILM COATED	60		1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8338	FLURBIPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1004	Current NDC, Legacy NDC, 2 package rows	20231109_5352162c-d09f-42be-9760-9d4bdfbe7788.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197724	flurbiprofen 100 MG Oral Tablet	PSN	5352162c-d09f-42be-9760-9d4bdfbe7788	1004
197724	flurbiprofen 100 MG Oral Tablet	SCD	5352162c-d09f-42be-9760-9d4bdfbe7788	1004

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8338-1	63629833801	30 TABLET, FILM COATED in 1 BOTTLE (63629-8338-1)	2021-12-23	0000-00-00	No	No	Current