spironolactone

Product NDC: 51655-861
Requested package NDC: 51655-861-52
11-digit product format: 516550861
Labeler code: 51655
Product ID: 51655-861_4bbc8ae6-5ac5-a88b-e063-6294a90a809f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: spironolactone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA205936
Marketing category: ANDA
Marketing start: 2023-02-15
Substance: SPIRONOLACTONE
Active strength: 50 mg/1
Pharmacologic classes: Aldosterone Antagonist [EPC]; Aldosterone Antagonists [MoA]
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 123 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
2026-02-19 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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205936-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205936-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205936-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: spironolactone
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SPIRONOLACTONE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
27O7W4T232	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198223	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f76b37a6-bcd4-2c8a-e053-6394a90aceea	Available on FDA.report

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, Related label table
NDC	Related label
51655-861-26	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
51655-861-26	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
51655-861-52	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
51655-861-52	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	Strength	SPL version
51655-861-26	spironolactone	90 in 1 BOTTLE, PLASTIC	TABLET	90		2
51655-861-52	spironolactone	30 in 1 BOTTLE, PLASTIC	TABLET	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-861	SPIRONOLACTONE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	2	2 package rows	20230707_f76b37a6-bcd4-2c8a-e053-6394a90aceea.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 ndc (package): 51655-861-52 ndc (product): 51655-861 ndc11 (package): 51655086152
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	REMEDYREPACK INC.	8b76a904-6c99-485a-a05f-13a36c5f720c	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198223	spironolactone 50 MG Oral Tablet	PSN	f76b37a6-bcd4-2c8a-e053-6394a90aceea	2
198223	spironolactone 50 MG Oral Tablet	SCD	f76b37a6-bcd4-2c8a-e053-6394a90aceea	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Status
51655-861-52	51655086152	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-861-52)	2023-06-30	0	Current