Etodolac

Product NDC: 60505-0040
11-digit product format: 605050040
Labeler code: 60505
Product ID: 60505-0040_41e18dea-7642-9715-53b0-db2b46d8265b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Etodolac
Dosage form: CAPSULE
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA075419
Marketing category: ANDA
Marketing start: 2003-05-01
Substance: ETODOLAC
Active strength: 300 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#

Ingredient, Strength table
Ingredient	Strength
ETODOLAC	300 mg/1

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

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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60505-0040-1	Etodolac	100 in 1 BOTTLE	CAPSULE	100		13

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-0040-1	EA - Each	60505-0040	5d5ae3a8-662f-4def-85e0-f7b92fdecdb6	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ETODOLAC	ACTIVE INGREDIENT	2M36281008	ETODOLAC CAPSULE [APOTEX CORP.]	2
ETODOLAC	ACTIVE MOIETY	2M36281008	ETODOLAC CAPSULE [APOTEX CORP.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ETODOLAC CAPSULE [APOTEX CORP.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ETODOLAC CAPSULE [APOTEX CORP.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ETODOLAC CAPSULE [APOTEX CORP.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ETODOLAC CAPSULE [APOTEX CORP.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ETODOLAC CAPSULE [APOTEX CORP.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ETODOLAC CAPSULE [APOTEX CORP.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ETODOLAC CAPSULE [APOTEX CORP.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ETODOLAC CAPSULE [APOTEX CORP.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ETODOLAC CAPSULE [APOTEX CORP.]	2
ETODOLAC	ACTIVE INGREDIENT	2M36281008	ETODOLAC CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]	1
ETODOLAC	ACTIVE MOIETY	2M36281008	ETODOLAC CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-0040	ETODOLAC CAPSULE [APOTEX CORP.]	12	Current NDC, Legacy NDC, 1 package rows	20240809_86c7b7b8-3a98-e5f4-c558-5b5caede6377.zip

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197684	etodolac 200 MG Oral Capsule	PSN	86c7b7b8-3a98-e5f4-c558-5b5caede6377	13
197685	etodolac 300 MG Oral Capsule	PSN	86c7b7b8-3a98-e5f4-c558-5b5caede6377	13
197685	etodolac 300 MG Oral Capsule	PSN	c2391373-9b5f-4eb9-b595-2439b15d2fbb	13
197684	etodolac 200 MG Oral Capsule	SCD	86c7b7b8-3a98-e5f4-c558-5b5caede6377	13
197685	etodolac 300 MG Oral Capsule	SCD	86c7b7b8-3a98-e5f4-c558-5b5caede6377	13
197685	etodolac 300 MG Oral Capsule	SCD	c2391373-9b5f-4eb9-b595-2439b15d2fbb	13
197685	etodolac 300 MG Oral Capsule	PSN	7ec87ffd-057e-420c-b8f2-0a6eed4152be	4
197685	etodolac 300 MG Oral Capsule	SCD	7ec87ffd-057e-420c-b8f2-0a6eed4152be	4
197685	etodolac 300 MG Oral Capsule	PSN	85b6254b-21da-ea85-e053-2991aa0a7d51	2
197685	etodolac 300 MG Oral Capsule	SCD	85b6254b-21da-ea85-e053-2991aa0a7d51	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-0040-1	60505004001	100 CAPSULE in 1 BOTTLE (60505-0040-1)	100 capsule	2003-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Etodolac Capsules, USP 300 mg Rx only	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Etodolac Capsules, USP 200 and 300 mg Rx only	Apotex Corp. \| Apotex Inc.	2025-09-18	HUMAN PRESCRIPTION DRUG LABEL	13
Etodolac Capsules, USP 200 and 300 mg Rx only	A-S Medication Solutions	2021-06-15	HUMAN PRESCRIPTION DRUG LABEL	13
Etodolac Capsules, USP 200 and 300 mg Rx only	NuCare Pharmaceuticals,Inc.	2021-01-11	HUMAN PRESCRIPTION DRUG LABEL	2