SPIRONOLACTONE

Product NDC: 53489-329
11-digit product format: 534890329
Labeler code: 53489
Product ID: 53489-329_d58f76e0-60c3-42ec-8375-128cd42485f1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SPIRONOLACTONE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA089424
Marketing category: ANDA
Marketing start: 1986-07-23
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53489-329	53489-329-06	D	Discontinued by firm		2026-08-11
excluded package	package	53489-329	53489-329-07	D	Discontinued by firm		2026-08-11

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
A089424-001	SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23
A089424-002	SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11
A089424-003	SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089424-001	AB
A089424-002	AB
A089424-003	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	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089424-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	1999-08-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089424-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	1999-08-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089424-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	1986-07-23	`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	A089424-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089424-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089424-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089424-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089424-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089424-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089424-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089424-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089424-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089424-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089424-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089424-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089424-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089424-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089424-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089424-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089424-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089424-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089424-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089424-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089424-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089424-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089424-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089424-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089424-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089424-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089424-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089424-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089424-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089424-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089424-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089424-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089424-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089424-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089424-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089424-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089424-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089424-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089424-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089424-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: SPIRONOLACTONE
Listing expiration: 2027-12-31

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198222	Internal RxNorm lookup
198223	Internal RxNorm lookup
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
c23b6b9b-aec3-48a8-a518-76e4097f6479	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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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
53489-329-01	SPIRONOLACTONE	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	14
53489-329-02	SPIRONOLACTONE	50 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	50	14
53489-329-03	SPIRONOLACTONE	250 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	250	14
53489-329-05	SPIRONOLACTONE	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500	14
53489-329-06	SPIRONOLACTONE	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	14
53489-329-07	SPIRONOLACTONE	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	14
53489-329-10	SPIRONOLACTONE	1000 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	1000	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53489-329-01	EA - Each	53489-329	4e6dcced-ea2c-47df-b19b-8766c48fc762	1	2012-07-24
53489-329-05	EA - Each	53489-329	3c643ef8-0d71-4627-81fb-8495085f4a66	1	2012-07-24
53489-329-06	EA - Each	53489-329	e646fbb2-7b6f-4e52-9a64-516595660c82	1	2012-07-24
53489-329-07	EA - Each	53489-329	ed866c79-3477-45e6-a4a6-e391ffe83471	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 [BRYANT RANCH PREPACK]	1000
SPIRONOLACTONE	ACTIVE MOIETY	27O7W4T232	SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
Spironolactone	ACTIVE INGREDIENT	27O7W4T232	SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7
Spironolactone	ACTIVE MOIETY	27O7W4T232	SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7
crospovidone	INACTIVE INGREDIENT	68401960MK	SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7
docusate sodium	INACTIVE INGREDIENT	F05Q2T2JA0	SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7
povidones	INACTIVE INGREDIENT	FZ989GH94E	SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7
sodium starch glycolate type a potato	INACTIVE INGREDIENT	5856J3G2A2	SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7
triacetin	INACTIVE INGREDIENT	XHX3C3X673	SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53489-329	SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13	Current NDC, Legacy NDC, 7 package rows	20230126_c23b6b9b-aec3-48a8-a518-76e4097f6479.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 · 35 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SPIRONOLACTONE	SPIRONOLACTONE	Sun Pharmaceutical Industries, Inc.	c23b6b9b-aec3-48a8-a518-76e4097f6479	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424 ndc (product): 53489-329
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	be4aa233-1555-4972-858e-46343a710558	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	11d06acd-1351-4afd-a16a-f035758e2a27	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	ca194a2a-ed16-40f6-a78c-45c5f3392170	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	ebc4efec-7895-4298-8e75-360bb7992f8d	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	813d199a-9004-4102-8ade-cf877caedafb	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	bb1423e8-1517-44c5-98e0-99be24ce269b	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	2d0655d7-fda6-40c6-907c-acaba0e19987	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	1c31c953-05ce-475a-b93f-80aeb12bde95	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	10a5c989-66e3-494d-bfd8-b2d6df3be411	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	753bbc6f-2e50-49c1-b5bf-18f8411a1e8e	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	cae68fd6-5161-4650-bcde-6db98cbe6c8b	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	b7a1f1d6-0724-4ad9-a4f9-7b1fe910f95d	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	3791d79c-d960-4790-b689-ea32ddf7226a	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	cbc817de-5ea8-4139-9c13-02bac8ff93c3	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	2efb4720-625f-6616-b6f0-8b13a17c9d7e	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	d4cf1136-df3a-4fc2-9a21-9032949eca41	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Aphena Pharma Solutions - Tennessee, LLC	45232668-6952-80a0-e063-6294a90a6e4b	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	REMEDYREPACK INC.	7c59e03a-b058-4f6e-b104-0836d9b56392	2025-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424
SPIRONOLACTONE	SPIRONOLACTONE	Bryant Ranch Prepack	1b29888c-09f9-4cd5-9b4c-920bd159a727	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089424 application number: ANDA089424

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	b7a1f1d6-0724-4ad9-a4f9-7b1fe910f95d	1011
198222	spironolactone 100 MG Oral Tablet	SCD	b7a1f1d6-0724-4ad9-a4f9-7b1fe910f95d	1011
198222	spironolactone 100 MG Oral Tablet	PSN	d4cf1136-df3a-4fc2-9a21-9032949eca41	107
198222	spironolactone 100 MG Oral Tablet	SCD	d4cf1136-df3a-4fc2-9a21-9032949eca41	107
198222	spironolactone 100 MG Oral Tablet	PSN	1c31c953-05ce-475a-b93f-80aeb12bde95	103
198222	spironolactone 100 MG Oral Tablet	PSN	bb1423e8-1517-44c5-98e0-99be24ce269b	103
198222	spironolactone 100 MG Oral Tablet	SCD	1c31c953-05ce-475a-b93f-80aeb12bde95	103
198222	spironolactone 100 MG Oral Tablet	SCD	bb1423e8-1517-44c5-98e0-99be24ce269b	103
198222	spironolactone 100 MG Oral Tablet	PSN	1fe93db1-0012-4ff6-a4e6-04e2d7e9f638	21
198222	spironolactone 100 MG Oral Tablet	SCD	1fe93db1-0012-4ff6-a4e6-04e2d7e9f638	21
198222	spironolactone 100 MG Oral Tablet	PSN	4514fa40-613e-46f5-bee4-3edc7cc9863f	12
198222	spironolactone 100 MG Oral Tablet	SCD	4514fa40-613e-46f5-bee4-3edc7cc9863f	12
198222	spironolactone 100 MG Oral Tablet	PSN	66c46ede-4f56-436a-993b-006b4eb56fc3	10
198222	spironolactone 100 MG Oral Tablet	PSN	0cc23419-e6d5-4036-8011-dc1d2455e0cb	10
198222	spironolactone 100 MG Oral Tablet	SCD	0cc23419-e6d5-4036-8011-dc1d2455e0cb	10
198222	spironolactone 100 MG Oral Tablet	SCD	66c46ede-4f56-436a-993b-006b4eb56fc3	10
198222	spironolactone 100 MG Oral Tablet	PSN	f826c86a-0957-843d-e053-6394a90a5c7c	1
198222	spironolactone 100 MG Oral Tablet	PSN	731894f2-bb1b-4ff6-b8c4-b8722e173199	1
313096	spironolactone 25 MG Oral Tablet	PSN	731894f2-bb1b-4ff6-b8c4-b8722e173199	1
198223	spironolactone 50 MG Oral Tablet	PSN	731894f2-bb1b-4ff6-b8c4-b8722e173199	1
198222	spironolactone 100 MG Oral Tablet	SCD	731894f2-bb1b-4ff6-b8c4-b8722e173199	1
198222	spironolactone 100 MG Oral Tablet	SCD	f826c86a-0957-843d-e053-6394a90a5c7c	1
313096	spironolactone 25 MG Oral Tablet	SCD	731894f2-bb1b-4ff6-b8c4-b8722e173199	1
198223	spironolactone 50 MG Oral Tablet	SCD	731894f2-bb1b-4ff6-b8c4-b8722e173199	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53489-329-01	53489032901	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-01)	1986-07-23	0000-00-00	No	No	Current
53489-329-02	53489032902	50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-02)	1986-07-23	0000-00-00	No	No	Current
53489-329-03	53489032903	250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-03)	1986-07-23	0000-00-00	No	No	Current
53489-329-05	53489032905	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-05)	1986-07-23	0000-00-00	No	No	Current
53489-329-06	53489032906	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-06)	1986-07-23	0000-00-00	No	No	Current
53489-329-07	53489032907	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-07)	1986-07-23	0000-00-00	No	No	Current
53489-329-10	53489032910	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-10)	1986-07-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SPIRONOLACTONE	Sun Pharmaceutical Industries, Inc. \| Frontida BioPharm, Inc.	2026-07-31	HUMAN PRESCRIPTION DRUG LABEL	16
SPIRONOLACTONE	Bryant Ranch Prepack	2026-05-21	HUMAN PRESCRIPTION DRUG LABEL	103
SPIRONOLACTONE	Bryant Ranch Prepack	2026-05-21	HUMAN PRESCRIPTION DRUG LABEL	103
SPIRONOLACTONE	Bryant Ranch Prepack	2026-04-02	HUMAN PRESCRIPTION DRUG LABEL	1011
SPIRONOLACTONE	Bryant Ranch Prepack	2026-01-22	HUMAN PRESCRIPTION DRUG LABEL	107
SPIRONOLACTONE	REMEDYREPACK INC.	2025-08-13	HUMAN PRESCRIPTION DRUG LABEL	13
SPIRONOLACTONE	Bryant Ranch Prepack	2024-08-05	HUMAN PRESCRIPTION DRUG LABEL	21
SPIRONOLACTONE	Bryant Ranch Prepack	2024-08-05	HUMAN PRESCRIPTION DRUG LABEL	10
SPIRONOLACTONE	Bryant Ranch Prepack	2024-03-15	HUMAN PRESCRIPTION DRUG LABEL	10
SPIRONOLACTONE	A-S Medication Solutions	2023-04-16	HUMAN PRESCRIPTION DRUG LABEL	12
SPIRONOLACTONE	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-04-07	HUMAN PRESCRIPTION DRUG LABEL	1
SPIRONOLACTONE	NuCare Pharmaceuticals,Inc.	2023-03-30	HUMAN PRESCRIPTION DRUG LABEL	1
SPIRONOLACTONE	Bryant Ranch Prepack	2023-02-13	HUMAN PRESCRIPTION DRUG LABEL	7