Etodolac

Product NDC: 42254-121
11-digit product format: 422540121
Labeler code: 42254
Product ID: 42254-121_9c244c88-dcc4-44fb-b0d9-13732dc705f5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: etodolac
Dosage form: CAPSULE
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA075078
Marketing category: ANDA
Marketing start: 2010-03-31
Marketing end: 0000-00-00
Substance: ETODOLAC
Active strength: 300 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42254-121-90	2019-09-24	C162847	48780-1	9350213a-3d25-c013-e053-90daa90a1393	9c244c88-dcc4-44fb-b0d9-13732dc705f5

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42254-121-90	Etodolac	90 in 1 BOTTLE	CAPSULE	90		1

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42254-121-90	EA - Each	42254-121	ab1a4d48-9194-4d6f-89e9-fbc17d13a35c	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ETODOLAC	ACTIVE INGREDIENT	2M36281008	ETODOLAC CAPSULE [REBEL DISTRIBUTORS CORP]	1
ETODOLAC	ACTIVE MOIETY	2M36281008	ETODOLAC CAPSULE [REBEL DISTRIBUTORS CORP]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ETODOLAC CAPSULE [REBEL DISTRIBUTORS CORP]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	ETODOLAC CAPSULE [REBEL DISTRIBUTORS CORP]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	ETODOLAC CAPSULE [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ETODOLAC CAPSULE [REBEL DISTRIBUTORS CORP]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ETODOLAC CAPSULE [REBEL DISTRIBUTORS CORP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ETODOLAC CAPSULE [REBEL DISTRIBUTORS CORP]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	ETODOLAC CAPSULE [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ETODOLAC CAPSULE [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ETODOLAC CAPSULE [REBEL DISTRIBUTORS CORP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ETODOLAC CAPSULE [REBEL DISTRIBUTORS CORP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ETODOLAC CAPSULE [REBEL DISTRIBUTORS CORP]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ETODOLAC CAPSULE [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ETODOLAC CAPSULE [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ETODOLAC CAPSULE [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ETODOLAC CAPSULE [REBEL DISTRIBUTORS CORP]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42254-121	ETODOLAC CAPSULE [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20120316_9c244c88-dcc4-44fb-b0d9-13732dc705f5.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
197685	etodolac 300 MG Oral Capsule	PSN	9c244c88-dcc4-44fb-b0d9-13732dc705f5	1
197685	etodolac 300 MG Oral Capsule	SCD	9c244c88-dcc4-44fb-b0d9-13732dc705f5	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42254-121-90	42254012190	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Etodolac - Rebel Distributors Corp	Rebel Distributors Corp	2012-01-10	HUMAN PRESCRIPTION DRUG LABEL	1