Spironolactone

Product NDC: 53002-1707
Requested package NDC: 53002-1707-3
11-digit product format: 530021707
Labeler code: 53002
Product ID: 53002-1707_57446208-b1dc-4b64-87ab-11e55b7e7cb4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Spironolactone
Dosage form: TABLET
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA091426
Marketing category: ANDA
Marketing start: 2010-08-02
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: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53002-1707	53002-1707-3	I	Inactivated by FDA		2026-09-09

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53002-1707-0	2025-01-30	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
53002-1707-3	2025-01-30	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
53002-1707-6	2025-01-30	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
53002-1707-0	2023-06-07	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
53002-1707-3	2023-06-07	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
53002-1707-6	2023-06-07	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
53002-1707-0	2023-01-30	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
53002-1707-3	2023-01-30	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
53002-1707-6	2023-01-30	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53002-1707-0	Spironolactone	100 in 1 BOTTLE	TABLET	100	3
53002-1707-3	Spironolactone	30 in 1 BOTTLE	TABLET	30	3
53002-1707-6	Spironolactone	60 in 1 BOTTLE	TABLET	60	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-1707	SPIRONOLACTONE TABLET [RPK PHARMACEUTICALS, INC.]	3	Legacy NDC, 3 package rows	20230609_8fe48523-352d-4c1a-b65a-aa673d221d78.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198223	spironolactone 50 MG Oral Tablet	PSN	8fe48523-352d-4c1a-b65a-aa673d221d78	3
198223	spironolactone 50 MG Oral Tablet	SCD	8fe48523-352d-4c1a-b65a-aa673d221d78	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-1707-3	53002170703	30 TABLET in 1 BOTTLE (53002-1707-3)	30 tablet	2019-01-01	0000-00-00	No	No	Current