Spironolactone

Product NDC: 67544-310
11-digit product format: 675440310
Labeler code: 67544
Product ID: 67544-310_3c92f359-98a1-43c4-b639-58ab3a388ab3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: spironolactone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA040424
Marketing category: ANDA
Marketing start: 1981-02-03
Substance: SPIRONOLACTONE
Active strength: 25 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
A040424-001	SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2001-08-20
A040424-002	SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2001-08-20
A040424-003	SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2001-08-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040424-001	AB
A040424-002	AB
A040424-003	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	A040424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2001-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2001-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2001-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2001-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2001-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2001-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2001-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2001-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2001-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2001-08-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2001-08-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2001-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2001-08-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2001-08-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2001-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2001-08-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2001-08-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2001-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2001-08-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2001-08-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2001-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2001-08-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2001-08-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2001-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2001-08-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2001-08-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2001-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2001-08-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2001-08-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2001-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2001-08-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2001-08-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2001-08-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2001-08-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2001-08-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2001-08-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2001-08-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2001-08-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2001-08-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2001-08-20	`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	A040424-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040424-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040424-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040424-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040424-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040424-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040424-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040424-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040424-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040424-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040424-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040424-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040424-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040424-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040424-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040424-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040424-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040424-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040424-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040424-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040424-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040424-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040424-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040424-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040424-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040424-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040424-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040424-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040424-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040424-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040424-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040424-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040424-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040424-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040424-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040424-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040424-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040424-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040424-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040424-001	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	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
1c97ce61-8e49-4724-a636-d179479d346c	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	SPL version
67544-310-30	Spironolactone	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	3
67544-310-45	Spironolactone	45 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	45	3
67544-310-60	Spironolactone	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67544-310-30	EA - Each	67544-310	cfec6aac-ed1d-42b6-8ee9-16c06a9cc504	1	2019-05-02
67544-310-45	EA - Each	67544-310	d3f6cea6-6dd6-4870-bbe9-1cb4dfa9f729	1	2021-11-09
67544-310-60	EA - Each	67544-310	2ecca119-5534-4b32-acd1-93cc0ff90256	1	2018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67544-310	SPIRONOLACTONE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3	Current NDC, Legacy NDC, 3 package rows	20211016_1c97ce61-8e49-4724-a636-d179479d346c.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Spironolactone	SPIRONOLACTONE	Safecor Health LLC	7057c090-67c2-414c-9077-bed18ad4b0b3	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040424 application number: ANDA040424
Spironolactone	SPIRONOLACTONE	Bryant Ranch Prepack	ce792c44-421d-4274-a333-01e2297ee0a3	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040424 application number: ANDA040424
Spironolactone	SPIRONOLACTONE	Mylan Pharmaceuticals Inc.	beaf74db-4159-3b59-ef99-575c3ac99aa1	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040424 application number: ANDA040424
Spironolactone	SPIRONOLACTONE	Cardinal Health 107, LLC	48115c9e-c82f-438d-b178-dce1b73687db	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040424 application number: ANDA040424
Spironolactone	SPIRONOLACTONE	Mylan Institutional Inc.	7e1a8152-941a-4aa4-bcb0-83c04905678f	2025-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040424 application number: ANDA040424
Spironolactone	SPIRONOLACTONE	Aphena Pharma Solutions - Tennessee, LLC	1c97ce61-8e49-4724-a636-d179479d346c	2021-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040424 application number: ANDA040424 ndc (product): 67544-310

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	1c97ce61-8e49-4724-a636-d179479d346c	3
313096	spironolactone 25 MG Oral Tablet	SCD	1c97ce61-8e49-4724-a636-d179479d346c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67544-310-30	67544031030	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-310-30)	2014-12-19	0000-00-00	No	No	Current
67544-310-45	67544031045	45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-310-45)	2021-09-09	0000-00-00	No	No	Current
67544-310-60	67544031060	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-310-60)	2014-12-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Spironolactone - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2021-10-14	HUMAN PRESCRIPTION DRUG LABEL	3