Spironolactone

Product NDC: 42708-126
11-digit product format: 427080126
Labeler code: 42708
Product ID: 42708-126_5190401f-30e9-5394-e063-6294a90ab09b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Spironolactone
Dosage form: TABLET
Route: ORAL
Labeler: QPharma, Inc
Application: ANDA091426
Marketing category: ANDA
Marketing start: 2010-08-02
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 42.

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
A091426-001	SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02
A091426-002	SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02
A091426-003	SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091426-001	AB
A091426-002	AB
A091426-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091426-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091426-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091426-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091426-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091426-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091426-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091426-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091426-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091426-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091426-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091426-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091426-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091426-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091426-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091426-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091426-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091426-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091426-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091426-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091426-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091426-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091426-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091426-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091426-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091426-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091426-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091426-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091426-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091426-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091426-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091426-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091426-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091426-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091426-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091426-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091426-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091426-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091426-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091426-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091426-001	AB	1	`1e350fbaab3a…`

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
eb314e91-6dd5-4bdb-af35-5d147b20339c	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#

Effective, Related label table
Effective	Related label
2021-03-15	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
2021-03-15	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
2021-01-29	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
2021-01-29	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
42708-126-30	Spironolactone	30 in 1 BOTTLE	TABLET	30		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42708-126	SPIRONOLACTONE TABLET [QPHARMA, INC.]	5	Current NDC, Legacy NDC, 1 package rows	20241123_eb314e91-6dd5-4bdb-af35-5d147b20339c.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	Bryant Ranch Prepack	31aeab13-8f71-49f1-b101-8b0abb21b0dc	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091426 application number: ANDA091426
Spironolactone	SPIRONOLACTONE	QPharma, Inc	eb314e91-6dd5-4bdb-af35-5d147b20339c	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091426 application number: ANDA091426 ndc (product): 42708-126
Spironolactone	SPIRONOLACTONE	Amneal Pharmaceuticals of New York LLC	951b8948-dc0f-4aef-9910-82c252de936d	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091426 application number: ANDA091426
Spironolactone	SPIRONOLACTONE	PharmPak, Inc.	c450e66a-0f05-445e-b1df-df2b17a2f064	2022-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091426 application number: ANDA091426
Spironolactone	SPIRONOLACTONE	Amneal Pharmaceuticals LLC	fb66327e-8261-46ae-b39a-4fa79d520844	2020-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091426 application number: ANDA091426
Spironolactone	SPIRONOLACTONE	Aphena Pharma Solutions - Tennessee, LLC	bf58378f-8304-4799-b0c0-fad8697149ab	2018-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091426 application number: ANDA091426

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	eb314e91-6dd5-4bdb-af35-5d147b20339c	7
313096	spironolactone 25 MG Oral Tablet	SCD	eb314e91-6dd5-4bdb-af35-5d147b20339c	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42708-126-30	42708012630	30 TABLET in 1 BOTTLE (42708-126-30)	30 tablet	2018-05-23	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Spironolactone	QPharma, Inc \| Northwind Health Company, LLC	2026-05-11	HUMAN PRESCRIPTION DRUG LABEL	7