Oxaprozin

Product NDC
21695-100
11-digit product format
216950100
Labeler code
21695
Product ID
21695-100_e77d2b9e-84df-4733-b654-16e93618efce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxaprozin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA075849
Marketing category
ANDA
Marketing start
2010-09-08
Marketing end
0000-00-00
Substance
OXAPROZIN
Active strength
600 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-100IInactivated by FDA2026-08-03
excluded packagepackage21695-10021695-100-14IInactivated by FDA2026-08-03
excluded packagepackage21695-10021695-100-28IInactivated by FDA2026-08-03
excluded packagepackage21695-10021695-100-30IInactivated by FDA2026-08-03
excluded packagepackage21695-10021695-100-60IInactivated by FDA2026-08-03

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 2 · 110 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-100-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-100-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-100-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-100-28d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-100-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-100-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-100-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-100-28f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-100-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-100-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-100-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-100-282ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-100-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-100-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-100-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-100-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-100-14cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-100-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-100-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-100-28cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-100-14cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-100-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-100-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-100-28cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-100-14302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-100-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-100-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-100-28302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-100-14ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-100-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-100-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-100-28ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-100-140efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-100-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-100-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-100-280efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-100-14ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-100-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-100-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-100-28ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-100-14367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-100-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-100-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-100-28367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-100-14557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-100-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-100-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-100-28557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075849-001OXAPROZINOXAPROZIN600MGTABLET / ORAL2002-07-03

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075849-001OXAPROZIN600MGTABLET / ORAL2002-07-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075849-001OXAPROZIN600MGTABLET / ORAL2002-07-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A075849-001OXAPROZIN600MGTABLET / ORAL2002-07-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075849-001OXAPROZIN600MGTABLET / ORAL2002-07-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075849-001OXAPROZIN600MGTABLET / ORAL2002-07-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075849-001OXAPROZIN600MGTABLET / ORAL2002-07-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075849-001OXAPROZIN600MGTABLET / ORAL2002-07-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075849-001OXAPROZIN600MGTABLET / ORAL2002-07-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075849-001OXAPROZIN600MGTABLET / ORAL2002-07-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075849-001OXAPROZIN600MGTABLET / ORAL2002-07-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075849-001OXAPROZIN600MGTABLET / ORAL2002-07-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075849-001OXAPROZIN600MGTABLET / ORAL2002-07-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075849-001OXAPROZIN600MGTABLET / ORAL2002-07-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075849-001OXAPROZIN600MGTABLET / ORAL2002-07-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075849-001OXAPROZIN600MGTABLET / ORALAB2002-07-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075849-001OXAPROZIN600MGTABLET / ORALAB2002-07-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075849-001OXAPROZIN600MGTABLET / ORALAB2002-07-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075849-001OXAPROZIN600MGTABLET / ORALAB2002-07-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075849-001OXAPROZIN600MGTABLET / ORALAB2002-07-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075849-001OXAPROZIN600MGTABLET / ORALAB2002-07-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075849-001OXAPROZIN600MGTABLET / ORALAB2002-07-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A075849-001OXAPROZIN600MGTABLET / ORALAB2002-07-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075849-001OXAPROZIN600MGTABLET / ORALAB2002-07-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075849-001OXAPROZIN600MGTABLET / ORALAB2002-07-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075849-001OXAPROZIN600MGTABLET / ORALAB2002-07-033f01610625f2…
2019-09-15 20:21 UTC2019-09A075849-001OXAPROZIN600MGTABLET / ORALAB2002-07-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A075849-001OXAPROZIN600MGTABLET / ORALAB2002-07-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075849-001OXAPROZIN600MGTABLET / ORAL2002-07-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075849-001OXAPROZIN600MGTABLET / ORAL2002-07-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075849-001OXAPROZIN600MGTABLET / ORALAB2002-07-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075849-001OXAPROZIN600MGTABLET / ORALAB2002-07-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075849-001OXAPROZIN600MGTABLET / ORALAB2002-07-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075849-001OXAPROZIN600MGTABLET / ORALAB2002-07-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075849-001OXAPROZIN600MGTABLET / ORALAB2002-07-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A075849-001OXAPROZIN600MGTABLET / ORALAB2002-07-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A075849-001OXAPROZIN600MGTABLET / ORALAB2002-07-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075849-001OXAPROZIN600MGTABLET / ORALAB2002-07-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075849-001OXAPROZIN600MGTABLET / ORALAB2002-07-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075849-001OXAPROZIN600MGTABLET / ORALAB2002-07-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075849-001OXAPROZIN600MGTABLET / ORALAB2002-07-03cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075849-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075849-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075849-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075849-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075849-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075849-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075849-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075849-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075849-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075849-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075849-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075849-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075849-001AB1ea99ee380514…
2023-12-20 04:57 UTC2023-12A075849-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075849-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075849-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075849-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075849-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075849-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075849-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075849-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075849-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075849-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075849-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95b4bbb5-24e2-44a4-b351-d64e35d6e76aProduct name120250722
486cfca4-efa2-1446-eef2-3c74b667bb18Product name220170713

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-100-14Oxaprozin14 in 1 BOTTLETABLET, FILM COATED141
21695-100-28Oxaprozin28 in 1 BOTTLETABLET, FILM COATED281
21695-100-30Oxaprozin30 in 1 BOTTLETABLET, FILM COATED301
21695-100-60Oxaprozin60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-100-14EA - Each21695-1008a36ab75-b28a-4169-b694-bc21deefedd512012-07-24
21695-100-28EA - Each21695-10017e52004-f046-41a9-a834-b6a01e634f8a12012-07-24
21695-100-30EA - Each21695-10026728cb1-01f4-4a69-9a13-533ba04d921c12012-07-24
21695-100-60EA - Each21695-10060955e1c-c5ed-406f-aea6-c19cdc7b093912012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-100OXAPROZIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 4 package rows20110629_e77d2b9e-84df-4733-b654-16e93618efce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312132oxaprozin 600 MG Oral TabletPSNe77d2b9e-84df-4733-b654-16e93618efce1
312132oxaprozin 600 MG Oral TabletSCDe77d2b9e-84df-4733-b654-16e93618efce1
312132oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral TabletSYe77d2b9e-84df-4733-b654-16e93618efce1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-100-142169501001414 in 1 BOTTLEHistorical
21695-100-282169501002828 in 1 BOTTLEHistorical
21695-100-302169501003030 in 1 BOTTLEHistorical
21695-100-602169501006060 in 1 BOTTLEHistorical