Spironolactone

Product NDC: 63739-545
11-digit product format: 637390545
Labeler code: 63739
Product ID: 63739-545_cf80cf51-576c-3b92-e053-2995a90a5f60
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Spironolactone
Dosage form: TABLET
Route: ORAL
Labeler: McKesson Corporation dba SKY Packaging
Application: ANDA091426
Marketing category: ANDA
Marketing start: 2011-06-01
Marketing end: 0000-00-00
Substance: SPIRONOLACTONE
Active strength: 50 mg/1
Pharmacologic classes: Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63739-545		D	Discontinued by firm		2026-09-09
excluded package	package	63739-545	63739-545-10	D	Discontinued by firm		2026-09-09

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A091426-001	SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02
A091426-002	SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02
A091426-003	SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A091426-001	AB
A091426-002	AB
A091426-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091426-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091426-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091426-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091426-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091426-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091426-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091426-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091426-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091426-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091426-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091426-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091426-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091426-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091426-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091426-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091426-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091426-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091426-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091426-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091426-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091426-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091426-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091426-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091426-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091426-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091426-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091426-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091426-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091426-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091426-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091426-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091426-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091426-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091426-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091426-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091426-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091426-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091426-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091426-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091426-001	AB	1	`1e350fbaab3a…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63739-545-10	2020-07-22	C162847	48780-1	ab0e2407-2929-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63739-545-10	EA - Each	63739-545	79673e03-5386-4e8c-9ec7-45a6618911ad	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SPIRONOLACTONE	ACTIVE INGREDIENT	27O7W4T232	SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
SPIRONOLACTONE	ACTIVE MOIETY	27O7W4T232	SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
PEPPERMINT	INACTIVE INGREDIENT	V95R5KMY2B	SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
POLYETHYLENE GLYCOL 3000	INACTIVE INGREDIENT	SA1B764746	SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63739-545	SPIRONOLACTONE TABLET [MCKESSON CORPORATION DBA SKY PACKAGING]	15	Legacy NDC	20250115_01deb112-edf1-4ed6-bc04-672d02ce66ab.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Spironolactone	SPIRONOLACTONE	Bryant Ranch Prepack	31aeab13-8f71-49f1-b101-8b0abb21b0dc	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091426 application number: ANDA091426
Spironolactone	SPIRONOLACTONE	QPharma, Inc	eb314e91-6dd5-4bdb-af35-5d147b20339c	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091426 application number: ANDA091426
Spironolactone	SPIRONOLACTONE	Amneal Pharmaceuticals of New York LLC	951b8948-dc0f-4aef-9910-82c252de936d	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091426 application number: ANDA091426
Spironolactone	SPIRONOLACTONE	PharmPak, Inc.	c450e66a-0f05-445e-b1df-df2b17a2f064	2022-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091426 application number: ANDA091426
Spironolactone	SPIRONOLACTONE	Amneal Pharmaceuticals LLC	fb66327e-8261-46ae-b39a-4fa79d520844	2020-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091426 application number: ANDA091426
Spironolactone	SPIRONOLACTONE	Aphena Pharma Solutions - Tennessee, LLC	bf58378f-8304-4799-b0c0-fad8697149ab	2018-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091426 application number: ANDA091426

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63739-545-10	63739054510	10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-545-10) > 10 TABLET in 1 BLISTER PACK	10 blister pack	2011-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Spironolactone	McKesson Corporation dba SKY Packaging \| Legacy Pharmaceutical Packaging, LLC	2025-01-13	HUMAN PRESCRIPTION DRUG LABEL	15