FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
UniiMHJ80W9LRB
Rxcui312132

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

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