Spironolactone

Product NDC: 66336-916
11-digit product format: 663360916
Labeler code: 66336
Product ID: 66336-916_3924e768-3967-4e22-9b2c-ac8bb80dcc27
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: spironolactone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Dispensing Solutions, Inc.
Application: ANDA040750
Marketing category: ANDA
Marketing start: 2006-08-29
Marketing end: 0000-00-00
Substance: SPIRONOLACTONE
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
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
66336-916-30	2019-11-27	C162847	48780-1	9855d018-e492-cd31-e053-dbdaa90ab51a	SPIRONOLACTONE TABLETS, USP 25 mg, 50 mg, 100 mg
66336-916-60	2019-11-27	C162847	48780-1	9855d018-e492-cd31-e053-dbdaa90ab51a	SPIRONOLACTONE TABLETS, USP 25 mg, 50 mg, 100 mg

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66336-916-30	Spironolactone	30 in 1 BOTTLE	TABLET, FILM COATED	30		2
66336-916-60	Spironolactone	60 in 1 BOTTLE	TABLET, FILM COATED	60		2

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SPIRONOLACTONE	ACTIVE INGREDIENT	27O7W4T232	SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
SPIRONOLACTONE	ACTIVE MOIETY	27O7W4T232	SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66336-916	SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2	Legacy NDC, 2 package rows	20121002_843edb2a-b71e-4ca7-a011-95718c551583.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
313096	spironolactone 25 MG Oral Tablet	PSN	843edb2a-b71e-4ca7-a011-95718c551583	2
313096	spironolactone 25 MG Oral Tablet	SCD	843edb2a-b71e-4ca7-a011-95718c551583	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
66336-916-30	66336091630	30 in 1 BOTTLE	Historical
66336-916-60	66336091660	60 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SPIRONOLACTONE TABLETS, USP 25 mg, 50 mg, 100 mg	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2012-10-01	HUMAN PRESCRIPTION DRUG LABEL	2