Etodolac

Product NDC: 0093-1893
11-digit product format: 000931893
Labeler code: 0093
Product ID: 0093-1893_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: 2009-09-09
Marketing end: 2020-02-29
Substance: ETODOLAC
Active strength: 500 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
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316
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
0093-1893-01	EA - Each	0093-1893	23bcef3d-b898-4805-ae11-986f43033be0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ETODOLAC	ACTIVE INGREDIENT	2M36281008	ETODOLAC TABLET [DIRECT RX]	3
ETODOLAC	ACTIVE MOIETY	2M36281008	ETODOLAC TABLET [DIRECT RX]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ETODOLAC TABLET [DIRECT RX]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ETODOLAC TABLET [DIRECT RX]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ETODOLAC TABLET [DIRECT RX]	3
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	ETODOLAC TABLET [DIRECT RX]	3
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	ETODOLAC TABLET [DIRECT RX]	3
INDIGOTINDISULFONATE SODIUM	INACTIVE INGREDIENT	D3741U8K7L	ETODOLAC TABLET [DIRECT RX]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ETODOLAC TABLET [DIRECT RX]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ETODOLAC TABLET [DIRECT RX]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ETODOLAC TABLET [DIRECT RX]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ETODOLAC TABLET [DIRECT RX]	3
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	ETODOLAC TABLET [DIRECT RX]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ETODOLAC TABLET [DIRECT RX]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ETODOLAC TABLET [DIRECT RX]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ETODOLAC TABLET [DIRECT RX]	3
ETODOLAC	ACTIVE INGREDIENT	2M36281008	ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	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
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	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
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ETODOLAC TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	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 [AIDAREX PHARMACEUTICALS LLC]	2

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
199390	etodolac 500 MG Oral Tablet	PSN	c10d8ee3-ad39-4d07-9e35-4bc9202804a5	3
199390	etodolac 500 MG Oral Tablet	SCD	c10d8ee3-ad39-4d07-9e35-4bc9202804a5	3
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	dc441b8f-1012-4d07-bdb7-ce0c85480533	2
199390	etodolac 500 MG Oral Tablet	SCD	dc441b8f-1012-4d07-bdb7-ce0c85480533	2

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ETODOLAC	DIRECT RX	2015-11-10	HUMAN PRESCRIPTION DRUG LABEL	3
ETODOLAC TABLETS USP 0892 1893 Rx only	Aidarex Pharmaceuticals LLC	2013-12-31	HUMAN PRESCRIPTION DRUG LABEL	2

Etodolac

DailyMed Product Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Related DailyMed Labels#