Spironolactone

Product NDC: 50090-6539
11-digit product format: 500906539
Labeler code: 50090
Product ID: 50090-6539_76b5d6ad-0b7b-4781-b990-5ba036cf5a67
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Spironolactone
Dosage form: TABLET, COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA040750
Marketing category: ANDA
Marketing start: 2021-01-04
Substance: SPIRONOLACTONE
Active strength: 100 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
A040750-001	SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2006-08-29
A040750-002	SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2006-08-29
A040750-003	SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2006-08-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040750-001	AB
A040750-002	AB
A040750-003	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	A040750-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2006-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040750-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2006-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040750-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2006-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040750-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2006-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040750-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2006-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040750-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2006-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040750-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2006-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040750-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2006-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040750-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2006-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040750-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2006-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040750-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2006-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040750-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2006-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040750-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2006-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040750-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2006-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040750-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2006-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040750-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2006-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040750-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2006-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040750-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2006-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040750-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2006-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040750-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2006-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040750-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2006-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040750-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2006-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040750-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2006-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040750-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2006-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040750-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2006-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040750-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2006-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040750-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2006-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040750-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2006-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040750-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2006-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040750-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2006-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040750-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2006-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040750-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2006-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040750-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2006-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040750-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2006-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040750-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2006-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040750-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2006-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040750-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2006-08-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040750-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2006-08-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040750-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2006-08-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040750-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2006-08-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 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	A040750-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040750-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040750-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040750-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040750-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040750-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040750-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040750-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040750-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040750-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040750-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040750-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040750-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040750-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040750-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040750-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040750-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040750-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040750-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040750-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040750-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040750-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040750-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040750-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040750-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040750-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040750-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040750-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040750-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040750-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040750-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040750-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040750-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040750-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040750-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040750-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040750-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040750-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040750-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040750-001	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	100 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
198222	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
08738ad4-1607-4d55-af71-6790477353bd	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
50090-6539-0	Spironolactone	90 in 1 BOTTLE	TABLET, COATED	90		5
50090-6539-1	Spironolactone	30 in 1 BOTTLE	TABLET, COATED	30		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-6539-0	EA - Each	50090-6539	a4f3d317-d9d0-45da-bd9f-e12b7c9f4c11	1	2023-08-08
50090-6539-1	EA - Each	50090-6539	152b3b6e-c3a5-4b52-a8bc-89fd8ac247c6	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-6539	SPIRONOLACTONE TABLET, COATED [A-S MEDICATION SOLUTIONS]	3	Current NDC, 2 package rows	20230708_08738ad4-1607-4d55-af71-6790477353bd.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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Spironolactone	SPIRONOLACTONE	PD-Rx Pharmaceuticals, Inc.	73564b3d-8ede-4008-b75c-1277153b5bb6	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040750 application number: ANDA040750
Spironolactone	SPIRONOLACTONE	PD-Rx Pharmaceuticals, Inc.	8a66d90e-5450-4716-8c01-e7dc1967d00d	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040750 application number: ANDA040750
Spironolactone	SPIRONOLACTONE	PD-Rx Pharmaceuticals, Inc.	8cbe2215-744c-438a-b3d6-b7d6ae769231	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040750 application number: ANDA040750
Spironolactone	SPIRONOLACTONE	REMEDYREPACK INC.	8f0291a9-c8a6-4298-a540-23abc01fae09	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040750 application number: ANDA040750
Spironolactone	SPIRONOLACTONE	Coupler LLC	56050192-c499-64bd-e063-6294a90acbeb	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040750 application number: ANDA040750
Spironolactone	SPIRONOLACTONE	Coupler LLC	53454970-2c0f-54c3-e063-6294a90aac0a	2026-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040750 application number: ANDA040750
Spironolactone	SPIRONOLACTONE	REMEDYREPACK INC.	b119ed8a-289a-46c5-9778-6b07e4c061c4	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040750 application number: ANDA040750
Spironolactone	SPIRONOLACTONE	Proficient Rx LP	6782c1c1-d1ac-4c07-b7cb-a74699d2f9fe	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040750 application number: ANDA040750
Spironolactone	SPIRONOLACTONE	REMEDYREPACK INC.	7646ca22-710e-4a5c-9613-b829e2f9d5ce	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040750 application number: ANDA040750
Spironolactone	SPIRONOLACTONE	Proficient Rx LP	6867776e-b4fd-41db-8da8-a5af76eed280	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040750 application number: ANDA040750
Spironolactone	SPIRONOLACTONE	Direct_Rx	ffd2f3f5-c7c8-0028-e053-6394a90aaf17	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040750 application number: ANDA040750
Spironolactone	SPIRONOLACTONE	NuCare Pharmaceuticals,Inc.	4b9a20c4-46f2-d572-e063-6294a90a30ad	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040750 application number: ANDA040750
Spironolactone	SPIRONOLACTONE	NuCare Pharmaceuticals, Inc.	4b4af7e0-f35b-9bf6-e063-6294a90a83b9	2026-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040750 application number: ANDA040750
Spironolactone	SPIRONOLACTONE	Oxford Pharmaceuticals, LLC	852684dc-e1c6-4caa-bccb-10ac90bbb3bb	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040750 application number: ANDA040750
Spironolactone	SPIRONOLACTONE	Coupler LLC	472ee2ad-7e57-bef1-e063-6394a90a0206	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040750 application number: ANDA040750
Spironolactone	SPIRONOLACTONE	A-S Medication Solutions	bb29ea6f-c294-4895-9e9b-544d69651a35	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040750 application number: ANDA040750
Spironolactone	SPIRONOLACTONE	A-S Medication Solutions	c328f555-2da8-43ac-bc04-0e89d4d2aa53	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040750 application number: ANDA040750
Spironolactone	SPIRONOLACTONE	A-S Medication Solutions	cd64e343-e15e-43b1-88b5-a3d5ba23fedf	2025-11-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040750 application number: ANDA040750
Spironolactone	SPIRONOLACTONE	A-S Medication Solutions	08738ad4-1607-4d55-af71-6790477353bd	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040750 application number: ANDA040750 ndc (product): 50090-6539
Spironolactone	SPIRONOLACTONE	Preferred Pharmaceuticals Inc.	5e456f3c-f93e-41c6-80c5-a737ed70feda	2025-09-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040750 application number: ANDA040750

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
198222	spironolactone 100 MG Oral Tablet	PSN	08738ad4-1607-4d55-af71-6790477353bd	5
198222	spironolactone 100 MG Oral Tablet	SCD	08738ad4-1607-4d55-af71-6790477353bd	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50090-6539-0	50090653900	90 TABLET, COATED in 1 BOTTLE (50090-6539-0)	2023-06-29	No	No	Current
50090-6539-1	50090653901	30 TABLET, COATED in 1 BOTTLE (50090-6539-1)	2023-06-29	No	No	Current