Spironolactone

Product NDC: 68071-2606
11-digit product format: 680712606
Labeler code: 68071
Product ID: 68071-2606_e2b05fa7-01c1-4b77-e053-2a95a90a22e8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: spironolactone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA203512
Marketing category: ANDA
Marketing start: 2017-06-02
Marketing end: 0000-00-00
Substance: SPIRONOLACTONE
Active strength: 100 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
d335cba1-5b36-51c8-120a-594ec9d05330	Product name	5	20251114
25f5e2cf-3572-477b-994c-aa692751e5a8	Product name	2	20250616
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2606-3	2025-01-30	C162847	48780-1	2cef2736-ac7a-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE (spironolactone) tablets for oral use Initial U.S. Approval: 1960

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2606-3	Spironolactone	30 in 1 BOTTLE	TABLET, FILM COATED	30		3

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2606	SPIRONOLACTONE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	3	Legacy NDC, 1 package rows	20230715_d3d82e51-dd37-17d0-e053-2a95a90a9d9c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
27O7W4T232	SPIRONOLACTONE	52-01-7	SPIRONOLACTONE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198222	spironolactone 100 MG Oral Tablet	PSN	d3d82e51-dd37-17d0-e053-2a95a90a9d9c	3
198222	spironolactone 100 MG Oral Tablet	SCD	d3d82e51-dd37-17d0-e053-2a95a90a9d9c	3

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2606-3	68071260603	30 TABLET, FILM COATED in 1 BOTTLE (68071-2606-3)	2021-12-23	0000-00-00	No	No	Current
68071-2606-9	68071260609	90 TABLET, FILM COATED in 1 BOTTLE (68071-2606-9)	2021-12-23	0000-00-00	No	No	Current