Spironolactone

Product NDC: 53746-511
11-digit product format: 537460511
Labeler code: 53746
Product ID: 53746-511_0b757d66-e1f0-4d56-bbe0-2f0941f0a35e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Spironolactone
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
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: 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
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 · 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	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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091426-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2010-07-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091426-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2010-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091426-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2010-07-02	`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	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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091426-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091426-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091426-001	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	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 · 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
951b8948-dc0f-4aef-9910-82c252de936d	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508
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
53746-511-01	Spironolactone	100 in 1 BOTTLE	TABLET	100	20
53746-511-05	Spironolactone	500 in 1 BOTTLE	TABLET	500	20
53746-511-10	Spironolactone	1000 in 1 BOTTLE	TABLET	1000	20
53746-511-30	Spironolactone	30 in 1 BOTTLE	TABLET	30	20
53746-511-60	Spironolactone	60 in 1 BOTTLE	TABLET	60	20
53746-511-90	Spironolactone	90 in 1 BOTTLE	TABLET	90	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53746-511-01	EA - Each	53746-511	69704d41-1e99-4986-9557-27761c6e40b9	1	2014-02-04
53746-511-05	EA - Each	53746-511	e178305c-b546-4eb2-8bcc-574ff2d30ef2	1	2014-02-04
53746-511-10	EA - Each	53746-511	dd2f6b49-381e-46e0-9974-33fd97efb5d1	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SPIRONOLACTONE	ACTIVE INGREDIENT	27O7W4T232	SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	13
SPIRONOLACTONE	ACTIVE MOIETY	27O7W4T232	SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	13
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	13
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	13
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	13
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	13
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	13
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	13
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	13
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	13
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	13
PEPPERMINT	INACTIVE INGREDIENT	V95R5KMY2B	SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	13
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	13
POLYETHYLENE GLYCOL 3000	INACTIVE INGREDIENT	SA1B764746	SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	13
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	13
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	13
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	13
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	13
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	13
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	13
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	13
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	13
SPIRONOLACTONE	ACTIVE INGREDIENT	27O7W4T232	SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]	1
SPIRONOLACTONE	ACTIVE MOIETY	27O7W4T232	SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]	1
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]	1
PEPPERMINT	INACTIVE INGREDIENT	V95R5KMY2B	SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]	1
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	SPIRONOLACTONE TABLET [BLENHEIM PHARMACAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53746-511	SPIRONOLACTONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	19	Current NDC, Legacy NDC, 6 package rows	20241003_951b8948-dc0f-4aef-9910-82c252de936d.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
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 ndc (product): 53746-511
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
198222	spironolactone 100 MG Oral Tablet	PSN	951b8948-dc0f-4aef-9910-82c252de936d	20
313096	spironolactone 25 MG Oral Tablet	PSN	951b8948-dc0f-4aef-9910-82c252de936d	20
198223	spironolactone 50 MG Oral Tablet	PSN	951b8948-dc0f-4aef-9910-82c252de936d	20
198222	spironolactone 100 MG Oral Tablet	SCD	951b8948-dc0f-4aef-9910-82c252de936d	20
313096	spironolactone 25 MG Oral Tablet	SCD	951b8948-dc0f-4aef-9910-82c252de936d	20
198223	spironolactone 50 MG Oral Tablet	SCD	951b8948-dc0f-4aef-9910-82c252de936d	20
313096	spironolactone 25 MG Oral Tablet	PSN	88615d0b-ab11-092b-e053-2a95a90ac418	7
313096	spironolactone 25 MG Oral Tablet	PSN	eb314e91-6dd5-4bdb-af35-5d147b20339c	7
313096	spironolactone 25 MG Oral Tablet	SCD	88615d0b-ab11-092b-e053-2a95a90ac418	7
313096	spironolactone 25 MG Oral Tablet	SCD	eb314e91-6dd5-4bdb-af35-5d147b20339c	7
313096	spironolactone 25 MG Oral Tablet	PSN	10538860-d9ad-6cfd-e054-00144ff8d46c	1
313096	spironolactone 25 MG Oral Tablet	PSN	bf58378f-8304-4799-b0c0-fad8697149ab	1
313096	spironolactone 25 MG Oral Tablet	SCD	10538860-d9ad-6cfd-e054-00144ff8d46c	1
313096	spironolactone 25 MG Oral Tablet	SCD	bf58378f-8304-4799-b0c0-fad8697149ab	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53746-511-01	53746051101	100 TABLET in 1 BOTTLE (53746-511-01)	100 tablet	2010-08-02	0000-00-00	No	No	Current
53746-511-05	53746051105	500 TABLET in 1 BOTTLE (53746-511-05)	500 tablet	2010-08-02	0000-00-00	No	No	Current
53746-511-10	53746051110	1000 TABLET in 1 BOTTLE (53746-511-10)	1000 tablet	2010-08-02	0000-00-00	No	No	Current
53746-511-30	53746051130	30 TABLET in 1 BOTTLE (53746-511-30)	30 tablet	2010-08-02	0000-00-00	No	No	Current
53746-511-60	53746051160	60 TABLET in 1 BOTTLE (53746-511-60)	60 tablet	2010-08-02	0000-00-00	No	No	Current
53746-511-90	53746051190	90 TABLET in 1 BOTTLE (53746-511-90)	90 tablet	2010-08-02	0000-00-00	No	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
Spironolactone	Amneal Pharmaceuticals of New York LLC \| Amneal Pharmaceuticals Private Limited	2025-12-16	HUMAN PRESCRIPTION DRUG LABEL	20
Spironolactone	REMEDYREPACK INC.	2025-05-29	HUMAN PRESCRIPTION DRUG LABEL	16
Spironolactone	A-S Medication Solutions	2024-09-05	HUMAN PRESCRIPTION DRUG LABEL	37
Spironolactone 25mg	RedPharm Drug, Inc.	2024-07-11	HUMAN PRESCRIPTION DRUG LABEL	7
Spironolactone	Quality Care Products, LLC	2019-04-08	HUMAN PRESCRIPTION DRUG LABEL	2
Spironolactone	Aphena Pharma Solutions - Tennessee, LLC	2018-08-08	HUMAN PRESCRIPTION DRUG LABEL	1
Spironolactone Tablets, USP	Blenheim Pharmacal, Inc.	2015-03-02	HUMAN PRESCRIPTION DRUG LABEL	1