Etodolac

Product NDC: 60429-243
11-digit product format: 604290243
Labeler code: 60429
Product ID: 60429-243_27c3fd4a-9616-37c5-e063-6394a90a5d81
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Etodolac
Dosage form: CAPSULE
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA075078
Marketing category: ANDA
Marketing start: 1998-04-30
Substance: ETODOLAC
Active strength: 200 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: Etodolac
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ETODOLAC	200 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	2M36281008
Rxcui	197684, 197685, 197686, 199390

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60429-243-01	Etodolac	100 in 1 BOTTLE	CAPSULE	100		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60429-243-01	EA - Each	60429-243	a97e8969-896e-4885-bea2-f73edca1d888	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Etodolac	ACTIVE INGREDIENT	2M36281008	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
Etodolac	ACTIVE MOIETY	2M36281008	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
Gelatin	INACTIVE INGREDIENT	2G86QN327L	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
Isopropyl Alcohol	INACTIVE INGREDIENT	ND2M416302	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
Lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
Povidone	INACTIVE INGREDIENT	FZ989GH94E	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
SODIUM STARCH GLYCOLATE TYPE B POTATO	INACTIVE INGREDIENT	27NA468985	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	3
Etodolac	ACTIVE INGREDIENT	2M36281008	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Etodolac	ACTIVE MOIETY	2M36281008	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Gelatin	INACTIVE INGREDIENT	2G86QN327L	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Isopropyl Alcohol	INACTIVE INGREDIENT	ND2M416302	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Povidone	INACTIVE INGREDIENT	FZ989GH94E	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SODIUM STARCH GLYCOLATE TYPE B POTATO	INACTIVE INGREDIENT	27NA468985	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60429-243	ETODOLAC CAPSULE ETODOLAC TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	11	Current NDC, Legacy NDC, 1 package rows	20241212_cf17926c-ed90-4fd0-80af-ccee084075e8.zip

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
197684	etodolac 200 MG Oral Capsule	PSN	cf17926c-ed90-4fd0-80af-ccee084075e8	11
197685	etodolac 300 MG Oral Capsule	PSN	cf17926c-ed90-4fd0-80af-ccee084075e8	11
197686	etodolac 400 MG Oral Tablet	PSN	cf17926c-ed90-4fd0-80af-ccee084075e8	11
199390	etodolac 500 MG Oral Tablet	PSN	cf17926c-ed90-4fd0-80af-ccee084075e8	11
197684	etodolac 200 MG Oral Capsule	SCD	cf17926c-ed90-4fd0-80af-ccee084075e8	11
197685	etodolac 300 MG Oral Capsule	SCD	cf17926c-ed90-4fd0-80af-ccee084075e8	11
197686	etodolac 400 MG Oral Tablet	SCD	cf17926c-ed90-4fd0-80af-ccee084075e8	11
199390	etodolac 500 MG Oral Tablet	SCD	cf17926c-ed90-4fd0-80af-ccee084075e8	11
197684	etodolac 200 MG Oral Capsule	PSN	c9f3dc18-d81c-4b02-8ff4-240c247bcbdd	3
197685	etodolac 300 MG Oral Capsule	PSN	c9f3dc18-d81c-4b02-8ff4-240c247bcbdd	3
197686	etodolac 400 MG Oral Tablet	PSN	c9f3dc18-d81c-4b02-8ff4-240c247bcbdd	3
199390	etodolac 500 MG Oral Tablet	PSN	c9f3dc18-d81c-4b02-8ff4-240c247bcbdd	3
197684	etodolac 200 MG Oral Capsule	SCD	c9f3dc18-d81c-4b02-8ff4-240c247bcbdd	3
197685	etodolac 300 MG Oral Capsule	SCD	c9f3dc18-d81c-4b02-8ff4-240c247bcbdd	3
197686	etodolac 400 MG Oral Tablet	SCD	c9f3dc18-d81c-4b02-8ff4-240c247bcbdd	3
199390	etodolac 500 MG Oral Tablet	SCD	c9f3dc18-d81c-4b02-8ff4-240c247bcbdd	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60429-243-01	60429024301	100 CAPSULE in 1 BOTTLE (60429-243-01)	100 capsule	2011-07-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Etodolac Capsules and Tablets, USP	Golden State Medical Supply, Inc.	2024-11-25	HUMAN PRESCRIPTION DRUG LABEL	11
Etodolac Capsules, Tablets and ER Tablets, USP	Aphena Pharma Solutions - Tennessee, LLC	2019-12-19	HUMAN PRESCRIPTION DRUG LABEL	3

Etodolac

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#