SPIRONOLACTONE

Product NDC: 0615-8452
11-digit product format: 006158452
Labeler code: 0615
Product ID: 0615-8452_876a2024-3f0f-4afd-8229-4e05a6270315
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SPIRONOLACTONE
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
Application: ANDA202187
Marketing category: ANDA
Marketing start: 2019-12-13
Substance: SPIRONOLACTONE
Active strength: 50 mg/1
Pharmacologic classes: Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
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 · 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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202187-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-03-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202187-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-03-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202187-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-03-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202187-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2014-03-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202187-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2014-03-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202187-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2014-03-06	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202187-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202187-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202187-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202187-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202187-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202187-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: SPIRONOLACTONE
Listing expiration: 2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198223	Internal RxNorm lookup
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
e34fc3ca-1272-446b-8dc2-25b62add01c3	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0615-8452-39	SPIRONOLACTONE	30 in 1 BLISTER PACK	TABLET	30		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0615-8452	SPIRONOLACTONE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]	8	Current NDC, 1 package rows	20240806_e34fc3ca-1272-446b-8dc2-25b62add01c3.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	REMEDYREPACK INC.	860b08bf-c6c1-4310-8510-10b6779f3d59	2025-08-19	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 ndc (product): 0615-8452
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313096	spironolactone 25 MG Oral Tablet	PSN	e34fc3ca-1272-446b-8dc2-25b62add01c3	8
198223	spironolactone 50 MG Oral Tablet	PSN	e34fc3ca-1272-446b-8dc2-25b62add01c3	8
313096	spironolactone 25 MG Oral Tablet	SCD	e34fc3ca-1272-446b-8dc2-25b62add01c3	8
198223	spironolactone 50 MG Oral Tablet	SCD	e34fc3ca-1272-446b-8dc2-25b62add01c3	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0615-8452-39	00615845239	30 TABLET in 1 BLISTER PACK (0615-8452-39)	30 tablet	2023-03-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SPIRONOLACTONE	NCS HealthCare of KY, LLC dba Vangard Labs	2024-08-05	HUMAN PRESCRIPTION DRUG LABEL	8