Oxaprozin

Product NDC: 68151-0523
11-digit product format: 681510523
Labeler code: 68151
Product ID: 68151-0523_805836f4-3924-49e7-a677-96a8afcb35a3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxaprozin
Dosage form: TABLET
Route: ORAL
Labeler: Carilion Materials Management
Application: ANDA075845
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 concept	Relation	Version	Effective
95b4bbb5-24e2-44a4-b351-d64e35d6e76a	Product name	1	20250722
486cfca4-efa2-1446-eef2-3c74b667bb18	Product name	2	20170713

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68151-0523-0	2020-01-31	C162847	48780-1	9d75b9d1-0ecd-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use OXAPROZIN TABLETS safely and effectively. See full prescribing information for OXAPROZIN TABLETS. OXAPROZIN tablets, for oral use Initial U.S. Approval: 1992

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68151-0523-0	Oxaprozin	1 in 1 PACKAGE	TABLET	1		4

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXAPROZIN	ACTIVE INGREDIENT	MHJ80W9LRB	OXAPROZIN TABLET [CARILION MATERIALS MANAGEMENT]	2
OXAPROZIN	ACTIVE MOIETY	MHJ80W9LRB	OXAPROZIN TABLET [CARILION MATERIALS MANAGEMENT]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXAPROZIN TABLET [CARILION MATERIALS MANAGEMENT]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OXAPROZIN TABLET [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXAPROZIN TABLET [CARILION MATERIALS MANAGEMENT]	2
METHYLCELLULOSE (100 MPA.S)	INACTIVE INGREDIENT	4GFU244C4J	OXAPROZIN TABLET [CARILION MATERIALS MANAGEMENT]	2
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	OXAPROZIN TABLET [CARILION MATERIALS MANAGEMENT]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	OXAPROZIN TABLET [CARILION MATERIALS MANAGEMENT]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	OXAPROZIN TABLET [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OXAPROZIN TABLET [CARILION MATERIALS MANAGEMENT]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OXAPROZIN TABLET [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OXAPROZIN TABLET [CARILION MATERIALS MANAGEMENT]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68151-0523	OXAPROZIN TABLET [CARILION MATERIALS MANAGEMENT]	4	Legacy NDC, 1 package rows	20170706_3f166d0b-bc70-44ef-9dd8-2490383356b2.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MHJ80W9LRB	OXAPROZIN	21256-18-8	OXAPROZIN

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312132	oxaprozin 600 MG Oral Tablet	PSN	3f166d0b-bc70-44ef-9dd8-2490383356b2	4
312132	oxaprozin 600 MG Oral Tablet	SCD	3f166d0b-bc70-44ef-9dd8-2490383356b2	4
312132	oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral Tablet	SY	3f166d0b-bc70-44ef-9dd8-2490383356b2	4

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68151-0523-0	68151052300	1 in 1 PACKAGE	Historical