Oxaprozin

Product NDC
57664-391
11-digit product format
576640391
Labeler code
57664
Product ID
57664-391_42a465c9-3cca-49aa-95bf-2658b3437218
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxaprozin
Dosage form
TABLET
Route
ORAL
Labeler
Caraco Pharmaceutical Laboratories, Ltd.
Application
ANDA075844
Marketing category
ANDA
Marketing start
2002-01-03
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
2019-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57664-391DDiscontinued by firm2026-08-03
excluded packagepackage57664-39157664-391-08DDiscontinued by firm2026-08-03
excluded packagepackage57664-39157664-391-13DDiscontinued by firm2026-08-03
excluded packagepackage57664-39157664-391-18DDiscontinued 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 · 48 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 packagepackage57664-391-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-391-18d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-391-13d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-391-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-391-18f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-391-13f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-391-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-391-182ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-391-132ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-391-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-391-18a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-391-13a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-391-08cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-391-18cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-391-13cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-391-08cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-391-18cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-391-13cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-391-08302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-391-18302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-391-13302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-391-08ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-391-18ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-391-13ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-391-080efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-391-180efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57664-391-130efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-391-08ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-391-18ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57664-391-13ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57664-391-08367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57664-391-18367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57664-391-13367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57664-391-08557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57664-391-18557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57664-391-13557ba5c1ecfa…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
A075844-001OXAPROZINOXAPROZIN600MGTABLET / ORAL2002-01-03

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 UTC2026-02A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-033f01610625f2…
2019-09-15 20:21 UTC2019-09A075844-001OXAPROZIN600MGTABLET / ORALAB2002-01-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A075844-001OXAPROZIN600MGTABLET / ORALAB2002-01-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075844-001OXAPROZIN600MGTABLET / ORAL2002-01-03cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A075844-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075844-001AB1ea99ee380514…

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
57664-391-08EA - Each57664-3913f0a4a7e-1e98-4287-bc19-80fed57e1f3f12013-02-13
57664-391-13EA - Each57664-39136434924-3cbc-4330-af86-799751fd43e712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OxaprozinACTIVE INGREDIENTMHJ80W9LRBOXAPROZIN TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]2
OxaprozinACTIVE MOIETYMHJ80W9LRBOXAPROZIN TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXAPROZIN TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXAPROZIN TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]2
METHYLCELLULOSE (400 MPA.S)INACTIVE INGREDIENTO0GN6F9B2YOXAPROZIN TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOXAPROZIN TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HOXAPROZIN TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXAPROZIN TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXAPROZIN TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXAPROZIN TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]2
OXAPROZINACTIVE INGREDIENTMHJ80W9LRBOXAPROZIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
OXAPROZINACTIVE INGREDIENTMHJ80W9LRBOXAPROZIN TABLET [DIRECT RX]1
OXAPROZINACTIVE MOIETYMHJ80W9LRBOXAPROZIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
OXAPROZINACTIVE MOIETYMHJ80W9LRBOXAPROZIN TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXAPROZIN TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXAPROZIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXAPROZIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXAPROZIN TABLET [DIRECT RX]1
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4JOXAPROZIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
METHYLCELLULOSE (400 MPA.S)INACTIVE INGREDIENTO0GN6F9B2YOXAPROZIN TABLET [DIRECT RX]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AOXAPROZIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOXAPROZIN TABLET [DIRECT RX]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HOXAPROZIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HOXAPROZIN TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXAPROZIN TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXAPROZIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXAPROZIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXAPROZIN TABLET [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXAPROZIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXAPROZIN TABLET [DIRECT RX]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 TabletPSN18c897d3-47c2-461a-a0e7-0926453d45e31
312132oxaprozin 600 MG Oral TabletSCD18c897d3-47c2-461a-a0e7-0926453d45e31
312132oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral TabletSY18c897d3-47c2-461a-a0e7-0926453d45e31