Spironolactone

Product NDC: 68071-1992
11-digit product format: 680711992
Labeler code: 68071
Product ID: 68071-1992_48fbb654-bb62-73d9-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: spironolactone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA089424
Marketing category: ANDA
Marketing start: 1986-07-23
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: 2019-12-31
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	68071-1992		D	Discontinued by firm		2026-10-05
excluded package	package	68071-1992	68071-1992-3	D	Discontinued by firm		2026-10-05

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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-1992-3	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-1992-3	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-1992-3	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-1992-3	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-1992-3	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-1992-3	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-1992-3	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-1992-3	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-1992-3	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-1992-3	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-1992-3	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-1992-3	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68071-1992-3	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A089424-001	SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23
A089424-002	SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11
A089424-003	SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089424-001	AB
A089424-002	AB
A089424-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A089424-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A089424-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A089424-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A089424-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089424-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A089424-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089424-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089424-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089424-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089424-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089424-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089424-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089424-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089424-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089424-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089424-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089424-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089424-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089424-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089424-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089424-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089424-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089424-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089424-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089424-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089424-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089424-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089424-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089424-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089424-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089424-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089424-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089424-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089424-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089424-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089424-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089424-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089424-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089424-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089424-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-1992-3	2020-07-06	C162847	48780-1	9d75b9cf-d214-f424-e053-dadaa90a57ce	SPIRONOLACTONE TABLETS USP
68071-1992-3	2020-01-31	C162847	48780-1	9d75b9cf-d214-f424-e053-dadaa90a57ce	SPIRONOLACTONE TABLETS USP

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 2 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	cae68fd6-5161-4650-bcde-6db98cbe6c8b	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	b7a1f1d6-0724-4ad9-a4f9-7b1fe910f95d	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	3791d79c-d960-4790-b689-ea32ddf7226a	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	cbc817de-5ea8-4139-9c13-02bac8ff93c3	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	d4cf1136-df3a-4fc2-9a21-9032949eca41	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Aphena Pharma Solutions - Tennessee, LLC	45232668-6952-80a0-e063-6294a90a6e4b	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Aphena Pharma Solutions - Tennessee, LLC	fb961096-edbb-45ad-96b7-61c2f9b98cf9	2023-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Proficient Rx LP	416ce231-fc8d-4ba0-a1ce-d5e054cf025e	2023-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	A-S Medication Solutions	be568fbd-3c3d-417c-ae96-75a78ca4b7cd	2023-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	A-S Medication Solutions	4514fa40-613e-46f5-bee4-3edc7cc9863f	2023-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	A-S Medication Solutions	200b2a6a-f263-463e-a2e1-f4f74058a924	2023-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Asclemed USA, Inc.	731894f2-bb1b-4ff6-b8c4-b8722e173199	2023-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Proficient Rx LP	18f11eed-9ef6-43f6-8db0-720c27563871	2023-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SPIRONOLACTONE TABLETS USP	NuCare Pharmaceuticals, Inc.	2017-02-20	HUMAN PRESCRIPTION DRUG LABEL	1