Etodolac

Product NDC: 0093-0892
11-digit product format: 000930892
Labeler code: 0093
Product ID: 0093-0892_1ee010ea-688d-4978-85d7-3378027bc3a8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Etodolac
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA075009
Marketing category: ANDA
Marketing start: 1998-05-20
Marketing end: 2020-02-29
Substance: ETODOLAC
Active strength: 400 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bb9faa76-10d1-4b5f-ab9b-d6a26495edb7	Product name	1	20250311
0c3d95a8-02c3-425e-810b-2a14408d9a06	Product name	4	20250218
24aa5265-325f-0e21-8836-2c9a907c0454	Product name	2	20210601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-0892-01	EA - Each	0093-0892	e0045dc5-59fb-466d-aa1b-07093988bc9e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ETODOLAC	ACTIVE INGREDIENT	2M36281008	ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
ETODOLAC	ACTIVE INGREDIENT	2M36281008	ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
ETODOLAC	ACTIVE INGREDIENT	2M36281008	ETODOLAC TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
ETODOLAC	ACTIVE MOIETY	2M36281008	ETODOLAC TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
ETODOLAC	ACTIVE MOIETY	2M36281008	ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
ETODOLAC	ACTIVE MOIETY	2M36281008	ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ETODOLAC TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ETODOLAC TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ETODOLAC TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ETODOLAC TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ETODOLAC TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ETODOLAC TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ETODOLAC TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ETODOLAC TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ETODOLAC TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ETODOLAC TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ETODOLAC TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ETODOLAC TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ETODOLAC TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ETODOLAC TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
ETODOLAC	ACTIVE INGREDIENT	2M36281008	ETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
ETODOLAC	ACTIVE MOIETY	2M36281008	ETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	ETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ETODOLAC TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2M36281008	ETODOLAC	41340-25-4	ETODOLAC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197686	etodolac 400 MG Oral Tablet	PSN	11093e14-5d31-4079-8dd2-c69f722d2810	2
197686	etodolac 400 MG Oral Tablet	PSN	cb26ac8c-294b-4705-8dd9-8c96afc33b8c	2
197686	etodolac 400 MG Oral Tablet	PSN	dc441b8f-1012-4d07-bdb7-ce0c85480533	2
199390	etodolac 500 MG Oral Tablet	PSN	dc441b8f-1012-4d07-bdb7-ce0c85480533	2
197686	etodolac 400 MG Oral Tablet	SCD	11093e14-5d31-4079-8dd2-c69f722d2810	2
197686	etodolac 400 MG Oral Tablet	SCD	cb26ac8c-294b-4705-8dd9-8c96afc33b8c	2
197686	etodolac 400 MG Oral Tablet	SCD	dc441b8f-1012-4d07-bdb7-ce0c85480533	2
199390	etodolac 500 MG Oral Tablet	SCD	dc441b8f-1012-4d07-bdb7-ce0c85480533	2
197686	etodolac 400 MG Oral Tablet	PSN	7e2f72a2-a76f-46a0-9a0b-4414633bb864	1
197686	etodolac 400 MG Oral Tablet	SCD	7e2f72a2-a76f-46a0-9a0b-4414633bb864	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ETODOLAC TABLETS USP 0892 1893 Rx only	Aidarex Pharmaceuticals LLC	2013-12-31	HUMAN PRESCRIPTION DRUG LABEL	2
ETODOLAC TABLETS USP 0892 1893 Rx only	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2013-09-26	HUMAN PRESCRIPTION DRUG LABEL	2
ETODOLAC TABLETS USP 0892 1893 Rx only	H.J. Harkins Company, Inc.	2012-08-30	HUMAN PRESCRIPTION DRUG LABEL	2
ETODOLAC TABLETS USP Rx only	Rebel Distributors Corp	2011-12-27	HUMAN PRESCRIPTION DRUG LABEL	1

Etodolac

DailyMed Product Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Related DailyMed Labels#