spironolactone

Product NDC: 70518-4470
11-digit product format: 705184470
Labeler code: 70518
Product ID: 70518-4470_5b38b3cd-9301-e346-e063-6294a90ab713
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: spironolactone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA205936
Marketing category: ANDA
Marketing start: 2025-09-08
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 44.

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
A205936-001	SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18
A205936-002	SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18
A205936-003	SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205936-001	AB
A205936-002	AB
A205936-003	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 · 132 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
2026-10-15 13:18:30	2026-09	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205936-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2018-07-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205936-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2018-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205936-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2018-07-18	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A205936-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205936-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205936-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A205936-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205936-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205936-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205936-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205936-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205936-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205936-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205936-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205936-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205936-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205936-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205936-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205936-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205936-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205936-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205936-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205936-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205936-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205936-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205936-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205936-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205936-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205936-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205936-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205936-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205936-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205936-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205936-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205936-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205936-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205936-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205936-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205936-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205936-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205936-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205936-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205936-001	AB	1	`79d66fd596c7…`

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

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
70518-4470-0	spironolactone	100 in 1 BOX	TABLET, FILM COATED	100		1
70518-4470-1	spironolactone	1 in 1 POUCH	TABLET, FILM COATED	1		1

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
spironolactone	SPIRONOLACTONE	REMEDYREPACK INC.	8b76a904-6c99-485a-a05f-13a36c5f720c	2026-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936
spironolactone	SPIRONOLACTONE	Cardinal Health 107, LLC	96db5dee-7c01-4f96-8b1e-1fcd2103d0fe	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936
spironolactone	SPIRONOLACTONE	Northwind Health Company, LLC	f988aa11-60ed-411e-e053-6294a90a522a	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936
spironolactone	SPIRONOLACTONE	Northwind Health Company, LLC	f32e8109-73e1-a249-e053-2995a90a3fae	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936
spironolactone	SPIRONOLACTONE	Northwind Health Company, LLC	f76b37a6-bcd4-2c8a-e053-6394a90aceea	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936
spironolactone	SPIRONOLACTONE	Major Pharmaceuticals	0c45d793-6f2f-4622-b5ed-6875acfbc02b	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936
spironolactone	SPIRONOLACTONE	Zydus Lifesciences Limited	963af399-feb7-49d2-a59c-c19edad9c682	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936
spironolactone	SPIRONOLACTONE	Zydus Pharmaceuticals (USA) Inc.	99bbc053-0e41-4b4d-979a-db610908f2de	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205936 application number: ANDA205936

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	39d82d50-0b77-4ef5-96b8-c1e05044a82c	1
313096	spironolactone 25 MG Oral Tablet	SCD	39d82d50-0b77-4ef5-96b8-c1e05044a82c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4470-0	70518447000	100 POUCH in 1 BOX (70518-4470-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4470-1)	100 pouch	2025-09-08	No	No	Current
70518-4470-1	70518447001	1 in 1 POUCH					Historical