Inspra

Product NDC: 21695-797
11-digit product format: 216950797
Labeler code: 21695
Product ID: 21695-797_c7bc9486-8e61-4ba1-827f-2cd8c304b454
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: eplerenone
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp
Application: NDA021437
Marketing category: NDA
Marketing start: 2002-09-27
Marketing end: 0000-00-00
Substance: EPLERENONE
Active strength: 25 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
21695-797-90	2019-09-24	C162847	48780-1	934fe258-4881-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use INSPRA safely and effectively. See full prescribing information for INSPRA. INSPRA (eplerenone) tablet for oral use Initial U.S. Approval: 2002

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-797-90	Inspra	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
21695-797-90	EA - Each	21695-797	822bae7a-7e6f-4bf0-a01b-24287efd1b32	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
eplerenone	ACTIVE INGREDIENT	6995V82D0B	INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP]	1
eplerenone	ACTIVE MOIETY	6995V82D0B	INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP]	1
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP]	1
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP]	1
lactose	INACTIVE INGREDIENT	J2B2A4N98G	INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP]	1
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP]	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP]	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-797	INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110104_c7bc9486-8e61-4ba1-827f-2cd8c304b454.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
351256	eplerenone 25 MG Oral Tablet	PSN	c7bc9486-8e61-4ba1-827f-2cd8c304b454	1
402106	INSPRA 25 MG Oral Tablet	PSN	c7bc9486-8e61-4ba1-827f-2cd8c304b454	1
402106	eplerenone 25 MG Oral Tablet [Inspra]	SBD	c7bc9486-8e61-4ba1-827f-2cd8c304b454	1
351256	eplerenone 25 MG Oral Tablet	SCD	c7bc9486-8e61-4ba1-827f-2cd8c304b454	1
402106	Inspra 25 MG Oral Tablet	SY	c7bc9486-8e61-4ba1-827f-2cd8c304b454	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-797-90	21695079790	90 in 1 BOTTLE	Historical