Oxaprozin

Product NDC
0185-0141
Requested package NDC
0185-0141-01
11-digit product format
001850141
Labeler code
0185
Product ID
0185-0141_8d2b7990-fbe5-426e-86f3-b30b3cbc0dc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxaprozin
Dosage form
TABLET
Route
ORAL
Labeler
Eon Labs, Inc.
Application
ANDA075845
Marketing category
ANDA
Marketing start
2001-01-31
Marketing end
0000-00-00
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
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0185-01410185-0141-01DDiscontinued by firm2026-08-03

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0185-01410185-0141-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0185-01410185-0141-01DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
A075845-001OXAPROZINOXAPROZIN600MGTABLET / ORALAB2001-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075845-001AB

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 UTC2026-02A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-313f01610625f2…
2019-09-15 20:21 UTC2019-09A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075845-001OXAPROZIN600MGTABLET / ORALAB2001-01-31cb3db0bc1861…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075845-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075845-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075845-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075845-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075845-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075845-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075845-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075845-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075845-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075845-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075845-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075845-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075845-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075845-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075845-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075845-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075845-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075845-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075845-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075845-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075845-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075845-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075845-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075845-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075845-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075845-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075845-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075845-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075845-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075845-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075845-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075845-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075845-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075845-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075845-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075845-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075845-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075845-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075845-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075845-001AB1cb3db0bc1861…

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0185-0141-01EA - Each0185-01415eaa2592-0aab-4bed-b791-25cd1c24acc912012-07-24
0185-0141-05EA - Each0185-014167b5e7e3-8407-4668-8531-8fbead25323612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXAPROZINACTIVE INGREDIENTMHJ80W9LRBOXAPROZIN TABLET [EON LABS, INC.]24
OXAPROZINACTIVE MOIETYMHJ80W9LRBOXAPROZIN TABLET [EON LABS, INC.]24
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXAPROZIN TABLET [EON LABS, INC.]24
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOXAPROZIN TABLET [EON LABS, INC.]24
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXAPROZIN TABLET [EON LABS, INC.]24
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4JOXAPROZIN TABLET [EON LABS, INC.]24
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUOXAPROZIN TABLET [EON LABS, INC.]24
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOXAPROZIN TABLET [EON LABS, INC.]24
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HOXAPROZIN TABLET [EON LABS, INC.]24
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXAPROZIN TABLET [EON LABS, INC.]24
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXAPROZIN TABLET [EON LABS, INC.]24
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXAPROZIN TABLET [EON LABS, INC.]24
OXAPROZINACTIVE INGREDIENTMHJ80W9LRBOXAPROZIN TABLET [CARILION MATERIALS MANAGEMENT]2
OXAPROZINACTIVE MOIETYMHJ80W9LRBOXAPROZIN TABLET [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXAPROZIN TABLET [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOXAPROZIN TABLET [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXAPROZIN TABLET [CARILION MATERIALS MANAGEMENT]2
METHYLCELLULOSE (100 MPA.S)INACTIVE INGREDIENT4GFU244C4JOXAPROZIN TABLET [CARILION MATERIALS MANAGEMENT]2
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUOXAPROZIN TABLET [CARILION MATERIALS MANAGEMENT]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOXAPROZIN TABLET [CARILION MATERIALS MANAGEMENT]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HOXAPROZIN TABLET [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXAPROZIN TABLET [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXAPROZIN TABLET [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXAPROZIN TABLET [CARILION MATERIALS MANAGEMENT]2
OXAPROZINACTIVE INGREDIENTMHJ80W9LRBOXAPROZIN TABLET [DIRECT RX]1
OXAPROZINACTIVE INGREDIENTMHJ80W9LRBOXAPROZIN TABLET [DISPENSING SOLUTIONS, INC.]1
OXAPROZINACTIVE MOIETYMHJ80W9LRBOXAPROZIN TABLET [DIRECT RX]1
OXAPROZINACTIVE MOIETYMHJ80W9LRBOXAPROZIN TABLET [DISPENSING SOLUTIONS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXAPROZIN TABLET [DISPENSING SOLUTIONS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXAPROZIN TABLET [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOXAPROZIN TABLET [DISPENSING SOLUTIONS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXAPROZIN TABLET [DISPENSING SOLUTIONS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXAPROZIN TABLET [DIRECT RX]1
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4JOXAPROZIN TABLET [DISPENSING SOLUTIONS, INC.]1
METHYLCELLULOSE (400 MPA.S)INACTIVE INGREDIENTO0GN6F9B2YOXAPROZIN TABLET [DIRECT RX]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUOXAPROZIN TABLET [DISPENSING SOLUTIONS, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOXAPROZIN TABLET [DISPENSING SOLUTIONS, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOXAPROZIN TABLET [DIRECT RX]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HOXAPROZIN TABLET [DISPENSING SOLUTIONS, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HOXAPROZIN TABLET [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXAPROZIN TABLET [DISPENSING SOLUTIONS, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXAPROZIN TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXAPROZIN TABLET [DISPENSING SOLUTIONS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXAPROZIN TABLET [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXAPROZIN TABLET [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXAPROZIN TABLET [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0185-0141OXAPROZIN TABLET [EON LABS, INC.]32Legacy NDC20231102_e2178942-ac37-4a88-83a9-221356b9a504.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312132oxaprozin 600 MG Oral TabletPSN42f56cc8-9843-4786-9bc6-5699a06676be103
312132oxaprozin 600 MG Oral TabletSCD42f56cc8-9843-4786-9bc6-5699a06676be103
312132oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral TabletSY42f56cc8-9843-4786-9bc6-5699a06676be103
312132oxaprozin 600 MG Oral TabletPSN3f166d0b-bc70-44ef-9dd8-2490383356b24
312132oxaprozin 600 MG Oral TabletSCD3f166d0b-bc70-44ef-9dd8-2490383356b24
312132oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral TabletSY3f166d0b-bc70-44ef-9dd8-2490383356b24
312132oxaprozin 600 MG Oral TabletPSN53d958ba-7a60-461b-8622-b73831a007253
312132oxaprozin 600 MG Oral TabletSCD53d958ba-7a60-461b-8622-b73831a007253
312132oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral TabletSY53d958ba-7a60-461b-8622-b73831a007253
312132oxaprozin 600 MG Oral TabletPSN73328d94-587c-4518-8856-98e2971246651
312132oxaprozin 600 MG Oral TabletSCD73328d94-587c-4518-8856-98e2971246651
312132oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral TabletSY73328d94-587c-4518-8856-98e2971246651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0185-0141-0100185014101100 TABLET in 1 BOTTLE (0185-0141-01) 100 tablet2001-01-310000-00-00NoNoCurrent