Spironolactone

Product NDC: 0228-2803
11-digit product format: 002282803
Labeler code: 0228
Product ID: 0228-2803_dc274a86-8ba4-4783-98ac-bd22249cac94
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Spironolactone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA040353
Marketing category: ANDA
Marketing start: 2007-01-03
Marketing end: 2020-11-30
Substance: SPIRONOLACTONE
Active strength: 25 mg/1
Pharmacologic classes: Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0228-2803-11	EA - Each	0228-2803	db91a90e-6260-492c-9f7e-1571e623d72d	1	2012-07-24
0228-2803-50	EA - Each	0228-2803	b9c9e666-17ed-4392-8f45-bab2a3bd251c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SPIRONOLACTONE	ACTIVE INGREDIENT	27O7W4T232	SPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
SPIRONOLACTONE	ACTIVE INGREDIENT	27O7W4T232	SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
SPIRONOLACTONE	ACTIVE MOIETY	27O7W4T232	SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
SPIRONOLACTONE	ACTIVE MOIETY	27O7W4T232	SPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	SPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	SPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	SPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	SPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
PEPPERMINT	INACTIVE INGREDIENT	V95R5KMY2B	SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
PEPPERMINT	INACTIVE INGREDIENT	V95R5KMY2B	SPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	SPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	SPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	SPIRONOLACTONE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	3
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	SPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]	3
SPIRONOLACTONE	ACTIVE INGREDIENT	27O7W4T232	SPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SPIRONOLACTONE	ACTIVE INGREDIENT	27O7W4T232	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SPIRONOLACTONE	ACTIVE MOIETY	27O7W4T232	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SPIRONOLACTONE	ACTIVE MOIETY	27O7W4T232	SPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	SPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	SPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	SPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	SPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	SPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
PEPPERMINT	INACTIVE INGREDIENT	V95R5KMY2B	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	SPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	SPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	SPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	SPIRONOLACTONE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	SPIRONOLACTONE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198222	spironolactone 100 MG Oral Tablet	PSN	617aef1f-3f2c-4d33-8baf-40995b8f6a24	3
313096	spironolactone 25 MG Oral Tablet	PSN	617aef1f-3f2c-4d33-8baf-40995b8f6a24	3
313096	spironolactone 25 MG Oral Tablet	PSN	857d5b98-d499-4a0d-9b40-2724bb45dd8c	3
198223	spironolactone 50 MG Oral Tablet	PSN	617aef1f-3f2c-4d33-8baf-40995b8f6a24	3
198222	spironolactone 100 MG Oral Tablet	SCD	617aef1f-3f2c-4d33-8baf-40995b8f6a24	3
313096	spironolactone 25 MG Oral Tablet	SCD	617aef1f-3f2c-4d33-8baf-40995b8f6a24	3
313096	spironolactone 25 MG Oral Tablet	SCD	857d5b98-d499-4a0d-9b40-2724bb45dd8c	3
198223	spironolactone 50 MG Oral Tablet	SCD	617aef1f-3f2c-4d33-8baf-40995b8f6a24	3
313096	spironolactone 25 MG Oral Tablet	PSN	4542d698-0299-4b6f-91a7-c8127384ca0c	1
313096	spironolactone 25 MG Oral Tablet	PSN	c22b0765-1777-4001-836a-2684daf2a35b	1
313096	spironolactone 25 MG Oral Tablet	SCD	4542d698-0299-4b6f-91a7-c8127384ca0c	1
313096	spironolactone 25 MG Oral Tablet	SCD	c22b0765-1777-4001-836a-2684daf2a35b	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SPIRONOLACTONE TABLETS, USP	Carilion Materials Management	2015-03-30	HUMAN PRESCRIPTION DRUG LABEL	3
SPIRONOLACTONE TABLETS, USP	Rebel Distributors Corp	2012-03-20	HUMAN PRESCRIPTION DRUG LABEL	1
SPIRONOLACTONE TABLETS, USP	Physicians Total Care, Inc.	2011-12-29	HUMAN PRESCRIPTION DRUG LABEL	3
SPIRONOLACTONE TABLETS, USP	State of Florida DOH Central Pharmacy	2010-03-29	HUMAN PRESCRIPTION DRUG LABEL	1

Spironolactone

DailyMed Product Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Related DailyMed Labels#