FDA.reportPublic FDA data

OXAPROZIN

Product NDC
62135-176
11-digit product format
621350176
Labeler code
62135
Product ID
62135-176_2526421a-bb2b-1e0b-e063-6394a90a42fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXAPROZIN
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC.
Application
ANDA075987
Marketing category
ANDA
Marketing start
2004-09-02
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
62135-176-18OXAPROZIN180 in 1 BOTTLETABLET1804
62135-176-60OXAPROZIN60 in 1 BOTTLETABLET604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-176-60EA - Each62135-176e355a96f-62e6-4ec4-bdcd-41fc8f8cea8a12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-176OXAPROZIN TABLET [CHARTWELL RX, LLC.]4Current NDC, Legacy NDC, 2 package rows20241025_db349233-9f09-471c-aeee-f91338d2ffe9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312132oxaprozin 600 MG Oral TabletPSNdb349233-9f09-471c-aeee-f91338d2ffe94
312132oxaprozin 600 MG Oral TabletSCDdb349233-9f09-471c-aeee-f91338d2ffe94
312132oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral TabletSYdb349233-9f09-471c-aeee-f91338d2ffe94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-176-1862135017618180 TABLET in 1 BOTTLE (62135-176-18) 180 tablet2022-08-220000-00-00NoNoCurrent
62135-176-606213501766060 TABLET in 1 BOTTLE (62135-176-60) 60 tablet2022-08-220000-00-00NoNoCurrent