Oxaprozin

Product NDC: 71335-0393
Requested package NDC: 71335-0393-2
11-digit product format: 713350393
Labeler code: 71335
Product ID: 71335-0393_115ad76f-3895-41b7-bc5a-a7a0975aca9d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxaprozin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA075855
Marketing category: ANDA
Marketing start: 2001-01-31
Substance: OXAPROZIN
Active strength: 600 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 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71335-0393	71335-0393-2	D	Discontinued by firm		excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A075855-001	OXAPROZIN	OXAPROZIN	600MG	TABLET / ORAL	AB	RS	2001-01-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A075855-001	AB

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075855-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2001-01-31	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075855-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075855-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075855-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075855-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075855-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075855-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075855-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075855-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075855-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075855-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075855-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075855-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075855-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075855-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075855-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075855-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075855-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075855-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075855-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075855-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075855-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075855-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075855-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075855-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075855-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075855-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075855-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075855-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075855-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075855-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075855-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075855-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075855-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075855-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075855-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075855-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075855-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075855-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075855-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075855-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Oxaprozin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXAPROZIN	600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
MHJ80W9LRB	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312132	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
dcb85e40-3427-4e56-910d-c1b07bb5c0fa	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
95b4bbb5-24e2-44a4-b351-d64e35d6e76a	Product name	1	20250722
486cfca4-efa2-1446-eef2-3c74b667bb18	Product name	2	20170713

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-0393-1	Oxaprozin	30 in 1 BOTTLE	TABLET, FILM COATED	30	4
71335-0393-2	Oxaprozin	20 in 1 BOTTLE	TABLET, FILM COATED	20	4
71335-0393-3	Oxaprozin	14 in 1 BOTTLE	TABLET, FILM COATED	14	4
71335-0393-4	Oxaprozin	60 in 1 BOTTLE	TABLET, FILM COATED	60	4
71335-0393-5	Oxaprozin	90 in 1 BOTTLE	TABLET, FILM COATED	90	4
71335-0393-6	Oxaprozin	6 in 1 BOTTLE	TABLET, FILM COATED	6	4
71335-0393-7	Oxaprozin	120 in 1 BOTTLE	TABLET, FILM COATED	120	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0393	OXAPROZIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	4	Current NDC, Legacy NDC, 7 package rows	20241004_dcb85e40-3427-4e56-910d-c1b07bb5c0fa.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxaprozin	OXAPROZIN	ST MARY'S MEDICAL PARK PHARMACY	e881dca6-004e-1c3e-e053-2a95a90a02ab	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075855 application number: ANDA075855
Oxaprozin	OXAPROZIN	Proficient Rx LP	e3fbea8c-bc0d-4dcd-a14e-a4575dceeea6	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075855 application number: ANDA075855
Oxaprozin	OXAPROZIN	Dr. Reddy's Laboratories Limited	da457b34-ca08-60df-045b-1ae80d2f7e71	2025-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075855 application number: ANDA075855
Oxaprozin	OXAPROZIN	Direct_Rx	284ce161-0a4a-8999-e063-6394a90aa60a	2024-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075855 application number: ANDA075855
Oxaprozin	OXAPROZIN	Bryant Ranch Prepack	dcb85e40-3427-4e56-910d-c1b07bb5c0fa	2024-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075855 application number: ANDA075855 ndc (package): 71335-0393-2 ndc (product): 71335-0393 ndc11 (package): 71335039302

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MHJ80W9LRB	OXAPROZIN	21256-18-8	OXAPROZIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312132	oxaprozin 600 MG Oral Tablet	PSN	dcb85e40-3427-4e56-910d-c1b07bb5c0fa	4
312132	oxaprozin 600 MG Oral Tablet	SCD	dcb85e40-3427-4e56-910d-c1b07bb5c0fa	4
312132	oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral Tablet	SY	dcb85e40-3427-4e56-910d-c1b07bb5c0fa	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-0393-2	71335039302	20 TABLET, FILM COATED in 1 BOTTLE (71335-0393-2)	2007-09-12	No	No	Current