Spironolactone

Product NDC: 0603-5763
Requested package NDC: 0603-5763-21
11-digit product format: 006035763
Labeler code: 0603
Product ID: 0603-5763_403aff2d-d9d0-45ed-8082-744ca8e21cbc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: spironolactone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Par Pharmaceutical
Application: ANDA040750
Marketing category: ANDA
Marketing start: 2006-08-29
Marketing end: 2021-07-31
Substance: SPIRONOLACTONE
Active strength: 25 mg/1
Pharmacologic classes: Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0603-5763	0603-5763-21	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0603-5763-21	EA - Each	0603-5763	5fbd49f3-26a7-4d99-ad42-07abdfd9297c	1	2012-07-24
0603-5763-28	EA - Each	0603-5763	2bb27632-a34d-4b8d-9b46-9dae434d5738	1	2012-07-24
0603-5763-30	EA - Each	0603-5763	e85d49b3-82e6-4b09-96d8-97b289e221af	1	2012-07-24
0603-5763-32	EA - Each	0603-5763	491be4eb-a031-4d69-8fda-725c9c71070d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SPIRONOLACTONE	ACTIVE INGREDIENT	27O7W4T232	SPIRONOLACTONE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	13
SPIRONOLACTONE	ACTIVE MOIETY	27O7W4T232	SPIRONOLACTONE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	13
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	SPIRONOLACTONE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	13
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SPIRONOLACTONE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	13
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SPIRONOLACTONE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SPIRONOLACTONE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	13
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SPIRONOLACTONE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	13
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SPIRONOLACTONE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	13
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	SPIRONOLACTONE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	13
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SPIRONOLACTONE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	13
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SPIRONOLACTONE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	13
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SPIRONOLACTONE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	13
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SPIRONOLACTONE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	13
SPIRONOLACTONE	ACTIVE INGREDIENT	27O7W4T232	SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
SPIRONOLACTONE	ACTIVE MOIETY	27O7W4T232	SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	2
SPIRONOLACTONE	ACTIVE INGREDIENT	27O7W4T232	SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
SPIRONOLACTONE	ACTIVE INGREDIENT	27O7W4T232	SPIRONOLACTONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SPIRONOLACTONE	ACTIVE MOIETY	27O7W4T232	SPIRONOLACTONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SPIRONOLACTONE	ACTIVE MOIETY	27O7W4T232	SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	SPIRONOLACTONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SPIRONOLACTONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	SPIRONOLACTONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SPIRONOLACTONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	SPIRONOLACTONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SPIRONOLACTONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	SPIRONOLACTONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SPIRONOLACTONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SPIRONOLACTONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SPIRONOLACTONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	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 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
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
313096	spironolactone 25 MG Oral Tablet	PSN	843edb2a-b71e-4ca7-a011-95718c551583	2
313096	spironolactone 25 MG Oral Tablet	SCD	843edb2a-b71e-4ca7-a011-95718c551583	2
198222	spironolactone 100 MG Oral Tablet	PSN	6c455943-ae60-46f0-9220-304395c09bdb	1
198222	spironolactone 100 MG Oral Tablet	PSN	7c850c17-9a7d-423a-86bd-ac108d1c7932	1
313096	spironolactone 25 MG Oral Tablet	PSN	6c455943-ae60-46f0-9220-304395c09bdb	1
313096	spironolactone 25 MG Oral Tablet	PSN	7c850c17-9a7d-423a-86bd-ac108d1c7932	1
198223	spironolactone 50 MG Oral Tablet	PSN	6c455943-ae60-46f0-9220-304395c09bdb	1
198222	spironolactone 100 MG Oral Tablet	SCD	6c455943-ae60-46f0-9220-304395c09bdb	1
198222	spironolactone 100 MG Oral Tablet	SCD	7c850c17-9a7d-423a-86bd-ac108d1c7932	1
313096	spironolactone 25 MG Oral Tablet	SCD	6c455943-ae60-46f0-9220-304395c09bdb	1
313096	spironolactone 25 MG Oral Tablet	SCD	7c850c17-9a7d-423a-86bd-ac108d1c7932	1
198223	spironolactone 50 MG Oral Tablet	SCD	6c455943-ae60-46f0-9220-304395c09bdb	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0603-5763-21	00603576321	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5763-21)	2006-08-29	2021-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SPIRONOLACTONE TABLETS, USP 25 mg, 50 mg, 100 mg	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	3
Spironolactone Tablets, USP 25 mg, 50 mg, 100 mg	Aphena Pharma Solutions - Tennessee, LLC	2018-09-04	HUMAN PRESCRIPTION DRUG LABEL	1
Spironolactone Tablets, USP 25 mg, 50 mg, 100 mg	Par Pharmaceutical \| Patheon Inc.	2018-08-27	HUMAN PRESCRIPTION DRUG LABEL	19
Spironolactone Tablets, USP 25 mg, 50 mg, 100 mg	A-S Medication Solutions	2018-01-10	HUMAN PRESCRIPTION DRUG LABEL	3
SPIRONOLACTONE TABLETS, USP 25 mg, 50 mg, 100 mg	NCS HealthCare of KY, Inc dba Vangard Labs	2016-06-09	HUMAN PRESCRIPTION DRUG LABEL	1
SPIRONOLACTONE TABLETS, USP 25 mg, 50 mg, 100 mg	Aidarex Pharmaceuticals LLC	2014-02-02	HUMAN PRESCRIPTION DRUG LABEL	1
SPIRONOLACTONE TABLETS, USP 25 mg, 50 mg, 100 mg	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2012-10-01	HUMAN PRESCRIPTION DRUG LABEL	2
SPIRONOLACTONE TABLETS, USP 25 mg, 50 mg, 100 mg	State of Florida DOH Central Pharmacy	2010-06-08	HUMAN PRESCRIPTION DRUG LABEL	1