oxaprozin

Product NDC
59762-6002
11-digit product format
597626002
Labeler code
59762
Product ID
59762-6002_fcadb9d0-958e-4d05-97a7-5b18dbf6e230
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxaprozin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Greenstone LLC
Application
NDA018841
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2013-03-27
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59762-6002DDiscontinued by firm2026-08-03
excluded packagepackage59762-600259762-6002-1DDiscontinued 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 · 4 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 packagepackage59762-6002-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59762-6002-1f5e01cc5f278…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
N018841-004DAYPROOXAPROZIN600MGTABLET / ORALRLD1992-10-29

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 UTC2026-02N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-293f01610625f2…
2019-09-15 20:21 UTC2019-09N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-293f0d92c62455…
2023-05-13 08:27 UTC2023-05N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-29053a50430f4f…
2023-01-26 05:58 UTC2023-01N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018841-004DAYPRO600MGTABLET / ORALABRLD, RS1992-10-29cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N018841-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018841-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018841-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018841-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018841-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018841-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018841-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018841-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018841-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018841-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018841-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018841-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018841-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018841-004AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018841-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018841-004AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018841-004AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018841-004AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018841-004AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018841-004AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018841-004AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N018841-004AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018841-004AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018841-004AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018841-004AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N018841-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018841-004AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018841-004AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018841-004AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018841-004AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018841-004AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018841-004AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018841-004AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018841-004AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018841-004AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018841-004AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018841-004AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018841-004AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018841-004AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018841-004AB1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-6002-1EA - Each59762-6002f6e9bea3-d58b-40f2-b02a-f187b4f64a2f12013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXAPROZINACTIVE INGREDIENTMHJ80W9LRBOXAPROZIN TABLET, FILM COATED [GREENSTONE LLC]1
OXAPROZINACTIVE MOIETYMHJ80W9LRBOXAPROZIN TABLET, FILM COATED [GREENSTONE LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXAPROZIN TABLET, FILM COATED [GREENSTONE LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOXAPROZIN TABLET, FILM COATED [GREENSTONE LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXAPROZIN TABLET, FILM COATED [GREENSTONE LLC]1
METHYLCELLULOSE (100 MPA.S)INACTIVE INGREDIENT4GFU244C4JOXAPROZIN TABLET, FILM COATED [GREENSTONE LLC]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUOXAPROZIN TABLET, FILM COATED [GREENSTONE LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOXAPROZIN TABLET, FILM COATED [GREENSTONE LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXAPROZIN TABLET, FILM COATED [GREENSTONE LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59762-6002-159762600201100 TABLET, FILM COATED in 1 BOTTLE (59762-6002-1) 2013-03-270000-00-00NoNoCurrent