Eplerenone

Product NDC: 42254-011
11-digit product format: 422540011
Labeler code: 42254
Product ID: 42254-011_4743a48b-d4b5-4054-85e1-9d64cc40de25
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Eplerenone
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp.
Application: ANDA078510
Marketing category: ANDA
Marketing start: 2008-08-01
Marketing end: 0000-00-00
Substance: EPLERENONE
Active strength: 50 mg/1
Pharmacologic classes: Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
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
6c046e2c-42d6-3179-f149-f207119f6ad5	Product name	6	20240530

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42254-011-90	2019-09-24	C162847	48780-1	9350213a-3d5b-c013-e053-90daa90a1393	These highlights do not include all the information needed to use Eplerenone Tablets safely and effectively. See full prescribing information for Eplerenone Tablets. Initial U.S. Approval: 2002

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42254-011-90	Eplerenone	90 in 1 BOTTLE	TABLET	90		1

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42254-011-90	EA - Each	42254-011	2f73f1ff-94a9-43c0-ba84-94b837107049	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
EPLERENONE	ACTIVE INGREDIENT	6995V82D0B	EPLERENONE TABLET [REBEL DISTRIBUTORS CORP.]	1
EPLERENONE	ACTIVE MOIETY	6995V82D0B	EPLERENONE TABLET [REBEL DISTRIBUTORS CORP.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	EPLERENONE TABLET [REBEL DISTRIBUTORS CORP.]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	EPLERENONE TABLET [REBEL DISTRIBUTORS CORP.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	EPLERENONE TABLET [REBEL DISTRIBUTORS CORP.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	EPLERENONE TABLET [REBEL DISTRIBUTORS CORP.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	EPLERENONE TABLET [REBEL DISTRIBUTORS CORP.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	EPLERENONE TABLET [REBEL DISTRIBUTORS CORP.]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	EPLERENONE TABLET [REBEL DISTRIBUTORS CORP.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	EPLERENONE TABLET [REBEL DISTRIBUTORS CORP.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	EPLERENONE TABLET [REBEL DISTRIBUTORS CORP.]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	EPLERENONE TABLET [REBEL DISTRIBUTORS CORP.]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42254-011	EPLERENONE TABLET [REBEL DISTRIBUTORS CORP.]	1	Legacy NDC, 1 package rows	20111118_4743a48b-d4b5-4054-85e1-9d64cc40de25.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6995V82D0B	EPLERENONE	107724-20-9	EPLERENONE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
351257	eplerenone 50 MG Oral Tablet	PSN	4743a48b-d4b5-4054-85e1-9d64cc40de25	1
351257	eplerenone 50 MG Oral Tablet	SCD	4743a48b-d4b5-4054-85e1-9d64cc40de25	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42254-011-90	42254001190	90 in 1 BOTTLE	Historical