Oxaprozin

Product NDC
52959-800
11-digit product format
529590800
Labeler code
52959
Product ID
52959-800_f180bf54-c92f-4597-ab9c-a91543ceedf6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxaprozin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA075855
Marketing category
ANDA
Marketing start
2001-01-31
Marketing end
0000-00-00
Substance
OXAPROZIN
Active strength
600 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-800-00Oxaprozin100 in 1 BOTTLETABLET, FILM COATED1001
52959-800-14Oxaprozin14 in 1 BOTTLETABLET, FILM COATED141
52959-800-15Oxaprozin15 in 1 BOTTLETABLET, FILM COATED151
52959-800-20Oxaprozin20 in 1 BOTTLETABLET, FILM COATED201
52959-800-21Oxaprozin21 in 1 BOTTLETABLET, FILM COATED211
52959-800-24Oxaprozin24 in 1 BOTTLETABLET, FILM COATED241
52959-800-28Oxaprozin28 in 1 BOTTLETABLET, FILM COATED281
52959-800-30Oxaprozin30 in 1 BOTTLETABLET, FILM COATED301
52959-800-40Oxaprozin40 in 1 BOTTLETABLET, FILM COATED401
52959-800-42Oxaprozin42 in 1 BOTTLETABLET, FILM COATED421
52959-800-45Oxaprozin45 in 1 BOTTLETABLET, FILM COATED451
52959-800-60Oxaprozin60 in 1 BOTTLETABLET, FILM COATED601
52959-800-90Oxaprozin90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-800-00EA - Each52959-800c10c25d7-7f23-4d72-b6a0-4a93cccefaf812015-10-02
52959-800-14EA - Each52959-800efdfe313-dad7-4b25-9c44-110c784a314d12012-07-24
52959-800-15EA - Each52959-800e4caa1cc-dfff-4404-94b1-4e68dd8c14fb12012-07-24
52959-800-20EA - Each52959-800c23d53d2-8266-4542-8d0d-e34b8478a2c512012-07-24
52959-800-21EA - Each52959-800fec132e0-bc7b-42c2-9f0a-02b03052af9512012-07-24
52959-800-24EA - Each52959-8007f468fbf-18bd-42e1-9194-379fd9b36bb812012-07-24
52959-800-28EA - Each52959-800d192b942-1d74-4d6e-b705-3b3f83e60efc12012-07-24
52959-800-30EA - Each52959-800731f9fa7-c205-472d-a0f2-dc4f34b2ace312012-07-24
52959-800-40EA - Each52959-800eb3a8225-1403-4841-a807-6d96cf2b549212012-07-24
52959-800-42EA - Each52959-800a7a9bcda-3b1e-4b99-80f9-d945d5d5fb5d12012-07-24
52959-800-45EA - Each52959-800b9206643-3ffd-4613-a2d5-85a869fa83ed12012-07-24
52959-800-60EA - Each52959-8003ea1bb4b-660e-47b2-83c0-6b700e27b26712012-07-24
52959-800-90EA - Each52959-80070038e6c-3a1d-49cc-848b-c6fcf8f94c2612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OxaprozinACTIVE INGREDIENTMHJ80W9LRBOXAPROZIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
oxaprozinACTIVE MOIETYMHJ80W9LRBOXAPROZIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UOXAPROZIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GOXAPROZIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]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
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XOXAPROZIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30OXAPROZIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
polydextroseINACTIVE INGREDIENTVH2XOU12IEOXAPROZIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1AOXAPROZIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2OXAPROZIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]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
triacetinINACTIVE INGREDIENTXHX3C3X673OXAPROZIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-800OXAPROZIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 13 package rows20111207_2f6bbff2-8855-4903-be12-11b9c8b9aae9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312132oxaprozin 600 MG Oral TabletPSN2f6bbff2-8855-4903-be12-11b9c8b9aae91
312132oxaprozin 600 MG Oral TabletSCD2f6bbff2-8855-4903-be12-11b9c8b9aae91
312132oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral TabletSY2f6bbff2-8855-4903-be12-11b9c8b9aae91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-800-0052959080000100 in 1 BOTTLEHistorical
52959-800-145295908001414 in 1 BOTTLEHistorical
52959-800-155295908001515 in 1 BOTTLEHistorical
52959-800-205295908002020 in 1 BOTTLEHistorical
52959-800-215295908002121 in 1 BOTTLEHistorical
52959-800-245295908002424 in 1 BOTTLEHistorical
52959-800-285295908002828 in 1 BOTTLEHistorical
52959-800-305295908003030 in 1 BOTTLEHistorical
52959-800-405295908004040 in 1 BOTTLEHistorical
52959-800-425295908004242 in 1 BOTTLEHistorical
52959-800-455295908004545 in 1 BOTTLEHistorical
52959-800-605295908006060 in 1 BOTTLEHistorical
52959-800-905295908009090 in 1 BOTTLEHistorical