spironolactone

Product NDC: 55700-934
Requested package NDC: 55700-934-30
11-digit product format: 557000934
Labeler code: 55700
Product ID: 55700-934_98f29b40-debc-42be-a6e0-f48c5c4021bf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: spironolactone
Dosage form: TABLET
Route: ORAL
Labeler: Quality Care Products, LLC
Application: ANDA205936
Marketing category: ANDA
Marketing start: 2021-09-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55700-934	55700-934-30	D	Discontinued by firm		2026-08-17

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 · 15 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	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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
A205936-001	SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18
A205936-002	SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18
A205936-003	SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205936-001	AB
A205936-002	AB
A205936-003	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	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`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	A205936-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205936-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205936-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205936-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205936-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205936-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205936-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205936-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205936-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205936-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205936-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205936-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205936-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205936-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205936-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205936-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205936-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205936-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205936-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205936-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205936-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205936-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205936-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205936-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205936-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205936-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205936-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205936-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205936-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205936-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205936-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205936-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205936-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205936-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205936-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205936-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205936-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205936-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205936-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205936-001	AB	1	`1e350fbaab3a…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55700-934-30	2025-01-13	C162847	48780-1	f386c649-c690-0266-e053-dadaa90a7c1a	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
55700-934-30	2023-01-30	C162847	48780-1	f386c649-c690-0266-e053-dadaa90a7c1a	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
55700-934-30	EA - Each	55700-934	e67c0fed-f9b5-4685-8ec5-71469a6d6480	1	2021-10-08

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
spironolactone	SPIRONOLACTONE	REMEDYREPACK INC.	8b76a904-6c99-485a-a05f-13a36c5f720c	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936
spironolactone	SPIRONOLACTONE	Cardinal Health 107, LLC	96db5dee-7c01-4f96-8b1e-1fcd2103d0fe	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936
spironolactone	SPIRONOLACTONE	Northwind Health Company, LLC	f988aa11-60ed-411e-e053-6294a90a522a	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936
spironolactone	SPIRONOLACTONE	Northwind Health Company, LLC	f32e8109-73e1-a249-e053-2995a90a3fae	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936
spironolactone	SPIRONOLACTONE	Northwind Health Company, LLC	f76b37a6-bcd4-2c8a-e053-6394a90aceea	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936
spironolactone	SPIRONOLACTONE	REMEDYREPACK INC.	eb27a2d2-1d28-4780-8e69-5fe613a0335e	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936
spironolactone	SPIRONOLACTONE	Major Pharmaceuticals	0c45d793-6f2f-4622-b5ed-6875acfbc02b	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936
spironolactone	SPIRONOLACTONE	Zydus Lifesciences Limited	963af399-feb7-49d2-a59c-c19edad9c682	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936
spironolactone	SPIRONOLACTONE	Zydus Pharmaceuticals (USA) Inc.	99bbc053-0e41-4b4d-979a-db610908f2de	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936
spironolactone	SPIRONOLACTONE	REMEDYREPACK INC.	39d82d50-0b77-4ef5-96b8-c1e05044a82c	2025-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936
Spironolactone	SPIRONOLACTONE	American Health Packaging	bd5ec154-b092-4c4d-8e72-ca2a2ef71a6d	2024-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936

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
55700-934-30	55700093430	30 TABLET in 1 BOTTLE (55700-934-30)	30 tablet	2021-09-01	0000-00-00	No	No	Current