Eplerenone

Product NDC: 0185-5369
11-digit product format: 001855369
Labeler code: 0185
Product ID: 0185-5369_697e0d84-e7d2-400e-baab-2ca055e4c6a4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Eplerenone
Dosage form: TABLET
Route: ORAL
Labeler: Eon Labs, Inc.
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: No
Listing certified through: 2023-12-31
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

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0185-5369-09	EA - Each	0185-5369	4ac5aa41-d256-44b4-b9be-40850d248b42	1	2012-07-24
0185-5369-30	EA - Each	0185-5369	2eda23bc-abd3-4af5-8295-6b2061f009ba	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

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0185-5369-09	00185536909	90 TABLET in 1 BOTTLE (0185-5369-09)	90 tablet	2008-08-01	0000-00-00	No	No	Current
0185-5369-30	00185536930	30 TABLET in 1 BOTTLE (0185-5369-30)	30 tablet	2008-08-01	0000-00-00	No	No	Current