OXAPROZIN

Product NDC: 72189-077
11-digit product format: 721890077
Labeler code: 72189
Product ID: 72189-077_9ff5086a-9f89-91ec-e053-2995a90a31b4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OXAPROZIN
Dosage form: TABLET
Route: ORAL
Labeler: DIRECT RX
Application: ANDA208633
Marketing category: ANDA
Marketing start: 2020-03-03
Marketing end: 0000-00-00
Substance: OXAPROZIN
Active strength: 600 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: 2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	72189-077		I	Inactivated by FDA		2026-08-03
excluded package	package	72189-077	72189-077-60	I	Inactivated by FDA		2026-08-03

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 · 30 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72189-077-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72189-077-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72189-077-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72189-077-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72189-077-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72189-077-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72189-077-60	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-077-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-077-60	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	72189-077-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	72189-077-60	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	72189-077-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
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	72189-077-60	`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	72189-077-60	`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	72189-077-60	`1332a3947898…`	`d4bfe170f9cd…`

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
A208633-001	OXAPROZIN	OXAPROZIN	600MG	TABLET / ORAL	AB		2017-05-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208633-001	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	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208633-001	OXAPROZIN	600MG	TABLET / ORAL	AB	2017-05-04	`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	A208633-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208633-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208633-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208633-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208633-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208633-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208633-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208633-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208633-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208633-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208633-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208633-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208633-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208633-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208633-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208633-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208633-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208633-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208633-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208633-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208633-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208633-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208633-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208633-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208633-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208633-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208633-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208633-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208633-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208633-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208633-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208633-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208633-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208633-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208633-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208633-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208633-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208633-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208633-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208633-001	AB	1	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72189-077-60	2023-01-30	C162847	48780-1	f386c64a-1d70-0266-e053-dadaa90a7c1a	OXAPROZIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-077-60	OXAPROZIN	60 in 1 BOTTLE	TABLET	60		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-077-60	EA - Each	72189-077	cfafc889-4999-4ce3-8e40-0eec6376bfd4	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-077	OXAPROZIN TABLET [DIRECT RX]	1	Legacy NDC, 1 package rows	20200304_9ff5086a-9f88-91ec-e053-2995a90a31b4.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
Oxaprozin	OXAPROZIN	Amneal Pharmaceuticals NY LLC	d9b0ca6c-4c53-4f6e-918b-02a8c472a194	2024-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208633 application number: ANDA208633
Oxaprozin	OXAPROZIN	Bryant Ranch Prepack	c157016e-0777-4ad7-89b8-487c47bb74cb	2023-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208633 application number: ANDA208633

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	9ff5086a-9f88-91ec-e053-2995a90a31b4	1
312132	oxaprozin 600 MG Oral Tablet	SCD	9ff5086a-9f88-91ec-e053-2995a90a31b4	1
312132	oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral Tablet	SY	9ff5086a-9f88-91ec-e053-2995a90a31b4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-077-60	72189007760	60 TABLET in 1 BOTTLE (72189-077-60)	60 tablet	2020-03-03	0000-00-00	No	No	Current