Oxaprozin

Product NDC
69238-1120
11-digit product format
692381120
Labeler code
69238
Product ID
69238-1120_b77a2557-2013-46ce-8d87-a25f17be5b89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxaprozin
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA208633
Marketing category
ANDA
Marketing start
2017-05-04
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
2026-12-31
Current FDA listing
Yes

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
A208633-001OXAPROZINOXAPROZIN600MGTABLET / ORALAB2017-05-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208633-001AB

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 UTC2026-02A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-043f01610625f2…
2019-09-15 20:21 UTC2019-09A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208633-001OXAPROZIN600MGTABLET / ORALAB2017-05-04cb3db0bc1861…

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 UTC2026-02A208633-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208633-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208633-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208633-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208633-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208633-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208633-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208633-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208633-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208633-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208633-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208633-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208633-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208633-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208633-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208633-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208633-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208633-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208633-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208633-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208633-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A208633-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208633-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208633-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208633-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A208633-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208633-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208633-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208633-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208633-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208633-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208633-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208633-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208633-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A208633-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A208633-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208633-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208633-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208633-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208633-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Oxaprozin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXAPROZIN600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MHJ80W9LRBInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312132Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9b0ca6c-4c53-4f6e-918b-02a8c472a194Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1120-1Oxaprozin100 in 1 BOTTLETABLET10010
69238-1120-5Oxaprozin500 in 1 BOTTLETABLET50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1120-1EA - Each69238-1120caadd9e8-8702-41ea-9f3d-66fe3e1b8f6312017-11-06
69238-1120-5EA - Each69238-1120cd3e7d36-5c3b-40f8-b189-1e84156f4c2f12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1120OXAPROZIN TABLET [AMNEAL PHARMACEUTICALS NY LLC]10Current NDC, Legacy NDC, 2 package rows20250107_d9b0ca6c-4c53-4f6e-918b-02a8c472a194.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OxaprozinOXAPROZINAmneal Pharmaceuticals NY LLCd9b0ca6c-4c53-4f6e-918b-02a8c472a1942024-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208633
application number: ANDA208633
ndc (product): 69238-1120
OxaprozinOXAPROZINBryant Ranch Prepackc157016e-0777-4ad7-89b8-487c47bb74cb2023-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208633
application number: ANDA208633

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312132oxaprozin 600 MG Oral TabletPSNd9b0ca6c-4c53-4f6e-918b-02a8c472a19410
312132oxaprozin 600 MG Oral TabletSCDd9b0ca6c-4c53-4f6e-918b-02a8c472a19410
312132oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral TabletSYd9b0ca6c-4c53-4f6e-918b-02a8c472a19410
312132oxaprozin 600 MG Oral TabletPSNc157016e-0777-4ad7-89b8-487c47bb74cb9
312132oxaprozin 600 MG Oral TabletSCDc157016e-0777-4ad7-89b8-487c47bb74cb9
312132oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral TabletSYc157016e-0777-4ad7-89b8-487c47bb74cb9
312132oxaprozin 600 MG Oral TabletPSN61cf2924-8dc0-7f5c-e053-2991aa0ac5271
312132oxaprozin 600 MG Oral TabletPSN9ff5086a-9f88-91ec-e053-2995a90a31b41
312132oxaprozin 600 MG Oral TabletSCD61cf2924-8dc0-7f5c-e053-2991aa0ac5271
312132oxaprozin 600 MG Oral TabletSCD9ff5086a-9f88-91ec-e053-2995a90a31b41
312132oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral TabletSY61cf2924-8dc0-7f5c-e053-2991aa0ac5271
312132oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral TabletSY9ff5086a-9f88-91ec-e053-2995a90a31b41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1120-169238112001100 TABLET in 1 BOTTLE (69238-1120-1) 100 tablet2017-05-040000-00-00NoNoCurrent
69238-1120-569238112005500 TABLET in 1 BOTTLE (69238-1120-5) 500 tablet2017-05-040000-00-00NoNoCurrent