FDA.reportPublic FDA data

Oxaprozin

Product NDC
55111-170
11-digit product format
551110170
Labeler code
55111
Product ID
55111-170_4aa1c6b5-21ff-e110-63cf-a5c0f1b66493
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxaprozin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA075855
Marketing category
ANDA
Marketing start
2001-01-31
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oxaprozin
Listing expiration
2027-12-31

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
55111-170-01Oxaprozin100 in 1 BOTTLETABLET, FILM COATED10011
55111-170-05Oxaprozin500 in 1 BOTTLETABLET, FILM COATED50011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-170-01EA - Each55111-17016dd316d-1746-4558-b9c3-d60ab371ca9d12012-07-24
55111-170-05EA - Each55111-170090df3c7-ec85-47e0-9f8f-2c5f9e147a5712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OxaprozinACTIVE INGREDIENTMHJ80W9LRBOXAPROZIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]2
oxaprozinACTIVE MOIETYMHJ80W9LRBOXAPROZIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UOXAPROZIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]2
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GOXAPROZIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]2
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8OXAPROZIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]2
hypromelloseINACTIVE INGREDIENT3NXW29V3WOOXAPROZIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XOXAPROZIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]2
magnesium stearateINACTIVE INGREDIENT70097M6I30OXAPROZIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]2
polydextroseINACTIVE INGREDIENTVH2XOU12IEOXAPROZIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]2
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1AOXAPROZIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]2
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2OXAPROZIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]2
starch, cornINACTIVE INGREDIENTO8232NY3SJOXAPROZIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPOXAPROZIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]2
triacetinINACTIVE INGREDIENTXHX3C3X673OXAPROZIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]2
OxaprozinACTIVE INGREDIENTMHJ80W9LRBOXAPROZIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
OXAPROZINACTIVE INGREDIENTMHJ80W9LRBOXAPROZIN TABLET [STAT RX USA LLC]1
OXAPROZINACTIVE MOIETYMHJ80W9LRBOXAPROZIN TABLET [STAT RX USA LLC]1
oxaprozinACTIVE MOIETYMHJ80W9LRBOXAPROZIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UOXAPROZIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXAPROZIN TABLET [STAT RX USA LLC]1
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GOXAPROZIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOXAPROZIN TABLET [STAT RX USA LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8OXAPROZIN TABLET [STAT RX USA LLC]1
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8OXAPROZIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOOXAPROZIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOXAPROZIN TABLET [STAT RX USA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXAPROZIN TABLET [STAT RX USA LLC]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XOXAPROZIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30OXAPROZIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXAPROZIN TABLET [STAT RX USA LLC]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEOXAPROZIN TABLET [STAT RX USA LLC]1
polydextroseINACTIVE INGREDIENTVH2XOU12IEOXAPROZIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1AOXAPROZIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AOXAPROZIN TABLET [STAT RX USA LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXAPROZIN TABLET [STAT RX USA LLC]1
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2OXAPROZIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXAPROZIN TABLET [STAT RX USA LLC]1
starch, cornINACTIVE INGREDIENTO8232NY3SJOXAPROZIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPOXAPROZIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXAPROZIN TABLET [STAT RX USA LLC]1
triacetinINACTIVE INGREDIENTXHX3C3X673OXAPROZIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673OXAPROZIN TABLET [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-170OXAPROZIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]10Current NDC, Legacy NDC, 2 package rows20250501_da457b34-ca08-60df-045b-1ae80d2f7e71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312132oxaprozin 600 MG Oral TabletPSNda457b34-ca08-60df-045b-1ae80d2f7e7111
312132oxaprozin 600 MG Oral TabletSCDda457b34-ca08-60df-045b-1ae80d2f7e7111
312132oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral TabletSYda457b34-ca08-60df-045b-1ae80d2f7e7111
312132oxaprozin 600 MG Oral TabletPSNe881dca6-004e-1c3e-e053-2a95a90a02ab4
312132oxaprozin 600 MG Oral TabletPSNdcb85e40-3427-4e56-910d-c1b07bb5c0fa4
312132oxaprozin 600 MG Oral TabletSCDdcb85e40-3427-4e56-910d-c1b07bb5c0fa4
312132oxaprozin 600 MG Oral TabletSCDe881dca6-004e-1c3e-e053-2a95a90a02ab4
312132oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral TabletSYe881dca6-004e-1c3e-e053-2a95a90a02ab4
312132oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral TabletSYdcb85e40-3427-4e56-910d-c1b07bb5c0fa4
312132oxaprozin 600 MG Oral TabletPSNcb1c0ab4-a102-46fe-b4cf-0a43fd6d91d93
312132oxaprozin 600 MG Oral TabletSCDcb1c0ab4-a102-46fe-b4cf-0a43fd6d91d93
312132oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral TabletSYcb1c0ab4-a102-46fe-b4cf-0a43fd6d91d93
312132oxaprozin 600 MG Oral TabletPSNde5ea439-a13c-441b-84e0-bc6937abf7621
312132oxaprozin 600 MG Oral TabletPSNe3fbea8c-bc0d-4dcd-a14e-a4575dceeea61
312132oxaprozin 600 MG Oral TabletPSN2f6bbff2-8855-4903-be12-11b9c8b9aae91
312132oxaprozin 600 MG Oral TabletPSN284ce161-0a4a-8999-e063-6394a90aa60a1
312132oxaprozin 600 MG Oral TabletSCDde5ea439-a13c-441b-84e0-bc6937abf7621
312132oxaprozin 600 MG Oral TabletSCDe3fbea8c-bc0d-4dcd-a14e-a4575dceeea61
312132oxaprozin 600 MG Oral TabletSCD2f6bbff2-8855-4903-be12-11b9c8b9aae91
312132oxaprozin 600 MG Oral TabletSCD284ce161-0a4a-8999-e063-6394a90aa60a1
312132oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral TabletSYde5ea439-a13c-441b-84e0-bc6937abf7621
312132oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral TabletSY2f6bbff2-8855-4903-be12-11b9c8b9aae91
312132oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral TabletSYe3fbea8c-bc0d-4dcd-a14e-a4575dceeea61
312132oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral TabletSY284ce161-0a4a-8999-e063-6394a90aa60a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55111-170-0155111017001100 TABLET, FILM COATED in 1 BOTTLE (55111-170-01) 2001-01-310000-00-00NoNoCurrent
55111-170-0555111017005500 TABLET, FILM COATED in 1 BOTTLE (55111-170-05) 2001-01-310000-00-00NoNoCurrent