Flurbiprofen

Product NDC: 0093-0711
11-digit product format: 000930711
Labeler code: 0093
Product ID: 0093-0711_ea4b1dbf-08e4-442d-a281-4c51712494b1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Flurbiprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
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: 2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0093-0711		D	Discontinued by firm	2026-10-15
excluded package	package	0093-0711	0093-0711-01	D	Discontinued by firm	2026-10-15
excluded package	package	0093-0711	0093-0711-05	D	Discontinued by firm	2026-10-15

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#

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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-0711-01	EA - Each	0093-0711	8335407a-20f3-441d-aa22-8c952496a814	1	2012-07-24
0093-0711-05	EA - Each	0093-0711	6b7aa0d3-a234-4210-b6df-763eda7eaf38	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLURBIPROFEN	ACTIVE INGREDIENT	5GRO578KLP	FLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
FLURBIPROFEN	ACTIVE MOIETY	5GRO578KLP	FLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	FLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	FLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	FLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	FLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	FLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	FLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-0711	FLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]	14	Legacy NDC	20241208_4e5c06f1-f279-4f2f-b10d-0f70005a27e6.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 · 2 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
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
197724	flurbiprofen 100 MG Oral Tablet	PSN	745337de-5378-4f1d-b457-d2f45f2df665	103
197724	flurbiprofen 100 MG Oral Tablet	SCD	745337de-5378-4f1d-b457-d2f45f2df665	103
197724	flurbiprofen 100 MG Oral Tablet	PSN	6c6a0daa-de1b-5455-e053-2991aa0a4cf8	6
197724	flurbiprofen 100 MG Oral Tablet	SCD	6c6a0daa-de1b-5455-e053-2991aa0a4cf8	6
197724	flurbiprofen 100 MG Oral Tablet	PSN	c7911338-4071-f1d2-e053-2995a90a903d	1
197724	flurbiprofen 100 MG Oral Tablet	SCD	c7911338-4071-f1d2-e053-2995a90a903d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-0711-01	00093071101	100 TABLET, FILM COATED in 1 BOTTLE (0093-0711-01)	1995-06-02	0000-00-00	No	No	Current
0093-0711-05	00093071105	500 TABLET, FILM COATED in 1 BOTTLE (0093-0711-05)	1995-06-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Flurbiprofen	PD-Rx Pharmaceuticals, Inc.	2025-10-17	HUMAN PRESCRIPTION DRUG LABEL	17
Flurbiprofen	Preferred Pharmaceuticals Inc.	2025-10-08	HUMAN PRESCRIPTION DRUG LABEL	8
Flurbiprofen	NuCare Pharmaceuticals,Inc.	2024-06-10	HUMAN PRESCRIPTION DRUG LABEL	6
Flurbiprofen	Medsource pharmaceuticals	2024-02-29	HUMAN PRESCRIPTION DRUG LABEL	3
Flurbiprofen	Bryant Ranch Prepack	2024-01-11	HUMAN PRESCRIPTION DRUG LABEL	103
Flurbiprofen	Bryant Ranch Prepack	2023-11-08	HUMAN PRESCRIPTION DRUG LABEL	1004
Flurbiprofen	Teva Pharmaceuticals USA, Inc.	2021-11-01	HUMAN PRESCRIPTION DRUG LABEL	14
Flurbiprofen	NuCare Pharmaceuticals,Inc.	2021-07-20	HUMAN PRESCRIPTION DRUG LABEL	1
Flurbiprofen	A-S Medication Solutions	2017-10-12	HUMAN PRESCRIPTION DRUG LABEL	6