SPIRONOLACTONE

Product NDC: 67296-2319
Requested package NDC: 67296-2319-9
11-digit product format: 672962319
Labeler code: 67296
Product ID: 67296-2319_59d86d41-c5ca-0f70-e063-6294a90ab4a8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SPIRONOLACTONE
Dosage form: TABLET
Route: ORAL
Labeler: Redpharm Drug
Application: ANDA202187
Marketing category: ANDA
Marketing start: 2019-12-13
Substance: SPIRONOLACTONE
Active strength: 25 mg/1
Pharmacologic classes: Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A202187-001	SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-03-06
A202187-002	SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-03-06
A202187-003	SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-03-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202187-001	AB
A202187-002	AB
A202187-003	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	A202187-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-03-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202187-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-03-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202187-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-03-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202187-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202187-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202187-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-03-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202187-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202187-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202187-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-03-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202187-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202187-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202187-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-03-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202187-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202187-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202187-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-03-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202187-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202187-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202187-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-03-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202187-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-03-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202187-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-03-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202187-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-03-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202187-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-03-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202187-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-03-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202187-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-03-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202187-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-03-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202187-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-03-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202187-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-03-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202187-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-03-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202187-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-03-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202187-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-03-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202187-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-03-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202187-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-03-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202187-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-03-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202187-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-03-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202187-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-03-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202187-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-03-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202187-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-03-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202187-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-03-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202187-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-03-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202187-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-03-06	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 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	A202187-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202187-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202187-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202187-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202187-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202187-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202187-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202187-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202187-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202187-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202187-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202187-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202187-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202187-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202187-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202187-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202187-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202187-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202187-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202187-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202187-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202187-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202187-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202187-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202187-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202187-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202187-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202187-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202187-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202187-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202187-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202187-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202187-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202187-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202187-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202187-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202187-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202187-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202187-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202187-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SPIRONOLACTONE	25 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
313096	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
59d86d3a-0f94-0b04-e063-6294a90a83f3	Available on FDA.report

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SPIRONOLACTONE	SPIRONOLACTONE	Redpharm Drug	59d86d3a-0f94-0b04-e063-6294a90a83f3	2026-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202187 application number: ANDA202187 ndc (package): 67296-2319-9 ndc (product): 67296-2319 ndc11 (package): 67296231909
SPIRONOLACTONE	SPIRONOLACTONE	Redpharm Drug	57d1c333-c229-54aa-e063-6394a90a84ce	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202187 application number: ANDA202187
SPIRONOLACTONE	SPIRONOLACTONE	NorthStar Rx LLC	ae0dcb4e-63df-459c-8e60-0caa817b8135	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202187 application number: ANDA202187
SPIRONOLACTONE	SPIRONOLACTONE	Aurobindo Pharma Limited	768563dc-a619-44dc-b97f-1a7e71fd56a0	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202187 application number: ANDA202187
SPIRONOLACTONE	SPIRONOLACTONE	NuCare Pharmaceuticals,Inc.	4239da9e-dd0c-9af0-e063-6394a90a3cbb	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202187 application number: ANDA202187
SPIRONOLACTONE	SPIRONOLACTONE	NuCare Pharmaceuticals, Inc.	2e5e782d-9ceb-d4a4-e063-6294a90aba3a	2025-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202187 application number: ANDA202187
SPIRONOLACTONE	SPIRONOLACTONE	NuCare Pharmaceuticals,Inc.	f98cc3be-cf59-e3d2-e053-6294a90a2ae0	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202187 application number: ANDA202187
SPIRONOLACTONE	SPIRONOLACTONE	NuCare Pharmaceuticals,Inc.	f9b79b4a-1a48-6247-e053-6394a90a2ae1	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202187 application number: ANDA202187
SPIRONOLACTONE	SPIRONOLACTONE	A-S Medication Solutions	a73e3dd9-4958-4a2c-853f-45b2810b1639	2024-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202187 application number: ANDA202187
SPIRONOLACTONE	SPIRONOLACTONE	NCS HealthCare of KY, LLC dba Vangard Labs	e34fc3ca-1272-446b-8dc2-25b62add01c3	2024-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202187 application number: ANDA202187
SPIRONOLACTONE	SPIRONOLACTONE	A-S Medication Solutions	781e0f31-a7c8-4a05-bb38-88f6dd874746	2024-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202187 application number: ANDA202187
SPIRONOLACTONE	SPIRONOLACTONE	A-S Medication Solutions	985524c3-9fb3-4874-9eb6-80b17af3d8ed	2023-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202187 application number: ANDA202187
SPIRONOLACTONE	SPIRONOLACTONE	A-S Medication Solutions	7ef0c2bb-9657-419e-848c-858893be50bc	2023-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202187 application number: ANDA202187

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	Sample	Exclude flag	Status
67296-2319-9	67296231909	90 TABLET in 1 BOTTLE (67296-2319-9)	90 tablet	2019-12-13	No	No	Current