Oxaprozin

Product NDC: 0185-0141
11-digit product format: 001850141
Labeler code: 0185
Product ID: 0185-0141_8d2b7990-fbe5-426e-86f3-b30b3cbc0dc1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxaprozin
Dosage form: TABLET
Route: ORAL
Labeler: Eon Labs, Inc.
Application: ANDA075845
Marketing category: ANDA
Marketing start: 2001-01-31
Marketing end: 0000-00-00
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: 2023-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0185-0141-01	EA - Each	0185-0141	5eaa2592-0aab-4bed-b791-25cd1c24acc9	1	2012-07-24
0185-0141-05	EA - Each	0185-0141	67b5e7e3-8407-4668-8531-8fbead253236	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXAPROZIN	ACTIVE INGREDIENT	MHJ80W9LRB	OXAPROZIN TABLET [EON LABS, INC.]	24
OXAPROZIN	ACTIVE MOIETY	MHJ80W9LRB	OXAPROZIN TABLET [EON LABS, INC.]	24
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXAPROZIN TABLET [EON LABS, INC.]	24
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OXAPROZIN TABLET [EON LABS, INC.]	24
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXAPROZIN TABLET [EON LABS, INC.]	24
METHYLCELLULOSE (100 CPS)	INACTIVE INGREDIENT	4GFU244C4J	OXAPROZIN TABLET [EON LABS, INC.]	24
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	OXAPROZIN TABLET [EON LABS, INC.]	24
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	OXAPROZIN TABLET [EON LABS, INC.]	24
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	OXAPROZIN TABLET [EON LABS, INC.]	24
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OXAPROZIN TABLET [EON LABS, INC.]	24
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OXAPROZIN TABLET [EON LABS, INC.]	24
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OXAPROZIN TABLET [EON LABS, INC.]	24
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
OXAPROZIN	ACTIVE INGREDIENT	MHJ80W9LRB	OXAPROZIN TABLET [DIRECT RX]	1
OXAPROZIN	ACTIVE INGREDIENT	MHJ80W9LRB	OXAPROZIN TABLET [DISPENSING SOLUTIONS, INC.]	1
OXAPROZIN	ACTIVE MOIETY	MHJ80W9LRB	OXAPROZIN TABLET [DIRECT RX]	1
OXAPROZIN	ACTIVE MOIETY	MHJ80W9LRB	OXAPROZIN TABLET [DISPENSING SOLUTIONS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXAPROZIN TABLET [DISPENSING SOLUTIONS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXAPROZIN TABLET [DIRECT RX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OXAPROZIN TABLET [DISPENSING SOLUTIONS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXAPROZIN TABLET [DISPENSING SOLUTIONS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXAPROZIN TABLET [DIRECT RX]	1
METHYLCELLULOSE (100 CPS)	INACTIVE INGREDIENT	4GFU244C4J	OXAPROZIN TABLET [DISPENSING SOLUTIONS, INC.]	1
METHYLCELLULOSE (400 MPA.S)	INACTIVE INGREDIENT	O0GN6F9B2Y	OXAPROZIN TABLET [DIRECT RX]	1
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	OXAPROZIN TABLET [DISPENSING SOLUTIONS, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	OXAPROZIN TABLET [DISPENSING SOLUTIONS, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	OXAPROZIN TABLET [DIRECT RX]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	OXAPROZIN TABLET [DISPENSING SOLUTIONS, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	OXAPROZIN TABLET [DIRECT RX]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OXAPROZIN TABLET [DISPENSING SOLUTIONS, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	OXAPROZIN TABLET [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OXAPROZIN TABLET [DISPENSING SOLUTIONS, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OXAPROZIN TABLET [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OXAPROZIN TABLET [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OXAPROZIN TABLET [DISPENSING SOLUTIONS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0185-0141	OXAPROZIN TABLET [EON LABS, INC.]	32	Legacy NDC	20231102_e2178942-ac37-4a88-83a9-221356b9a504.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312132	oxaprozin 600 MG Oral Tablet	PSN	42f56cc8-9843-4786-9bc6-5699a06676be	103
312132	oxaprozin 600 MG Oral Tablet	SCD	42f56cc8-9843-4786-9bc6-5699a06676be	103
312132	oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral Tablet	SY	42f56cc8-9843-4786-9bc6-5699a06676be	103
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
312132	oxaprozin 600 MG Oral Tablet	PSN	53d958ba-7a60-461b-8622-b73831a00725	3
312132	oxaprozin 600 MG Oral Tablet	SCD	53d958ba-7a60-461b-8622-b73831a00725	3
312132	oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral Tablet	SY	53d958ba-7a60-461b-8622-b73831a00725	3
312132	oxaprozin 600 MG Oral Tablet	PSN	73328d94-587c-4518-8856-98e297124665	1
312132	oxaprozin 600 MG Oral Tablet	SCD	73328d94-587c-4518-8856-98e297124665	1
312132	oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral Tablet	SY	73328d94-587c-4518-8856-98e297124665	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0185-0141-01	00185014101	100 TABLET in 1 BOTTLE (0185-0141-01)	100 tablet	2001-01-31	0000-00-00	No	No	Current
0185-0141-05	00185014105	500 TABLET in 1 BOTTLE (0185-0141-05)	500 tablet	2001-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxaprozin	Bryant Ranch Prepack	2023-11-01	HUMAN PRESCRIPTION DRUG LABEL	103
OXAPROZIN	DIRECT RX	2019-04-19	HUMAN PRESCRIPTION DRUG LABEL	3
Oxaprozin	Carilion Materials Management	2017-07-06	HUMAN PRESCRIPTION DRUG LABEL	4
Oxaprozin Tablets USP	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2013-07-03	HUMAN PRESCRIPTION DRUG LABEL	1

Oxaprozin

DailyMed Product Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#