Spironolactone

Product NDC: 68071-4374
11-digit product format: 680714374
Labeler code: 68071
Product ID: 68071-4374_1a555e97-0935-d52f-e063-6394a90ad7e3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: spironolactone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA203512
Marketing category: ANDA
Marketing start: 2017-06-02
Substance: SPIRONOLACTONE
Active strength: 50 mg/1
Pharmacologic classes: Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-4374-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-4374-3	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-4374-3	`1332a3947898…`	`d4bfe170f9cd…`

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
A203512-001	SPIRONOLACTONE	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2016-09-19
A203512-002	SPIRONOLACTONE	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2016-09-19
A203512-003	SPIRONOLACTONE	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2016-09-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203512-001	AB
A203512-002	AB
A203512-003	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	A203512-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2016-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203512-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2016-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203512-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2016-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203512-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2016-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203512-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2016-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203512-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2016-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203512-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2016-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203512-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2016-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203512-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2016-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203512-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2016-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203512-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2016-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203512-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2016-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203512-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2016-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203512-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2016-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203512-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2016-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203512-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2016-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203512-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2016-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203512-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2016-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203512-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2016-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203512-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2016-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203512-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2016-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203512-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2016-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203512-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2016-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203512-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2016-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203512-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2016-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203512-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2016-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203512-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2016-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203512-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2016-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203512-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2016-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203512-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2016-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203512-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2016-09-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203512-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2016-09-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203512-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2016-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203512-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2016-09-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203512-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2016-09-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203512-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2016-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203512-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2016-09-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203512-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2016-09-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203512-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2016-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203512-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2016-09-19	`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	A203512-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203512-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203512-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203512-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203512-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203512-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203512-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203512-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203512-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203512-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203512-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203512-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203512-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203512-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203512-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203512-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203512-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203512-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203512-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203512-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203512-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203512-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203512-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203512-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203512-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203512-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203512-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203512-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203512-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203512-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203512-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203512-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203512-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203512-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203512-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203512-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203512-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203512-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203512-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203512-001	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	50 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
198223	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
691bc5ca-5d5e-60c2-e053-2991aa0abb93	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
2024-06-07	Spironolactone tablets, USP
2023-01-30	Spironolactone tablets, USP
2021-02-16	Spironolactone tablets, USP
2021-01-29	Spironolactone tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-4374-3	Spironolactone	30 in 1 BOTTLE	TABLET, FILM COATED	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-4374	SPIRONOLACTONE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	5	Current NDC, Legacy NDC, 1 package rows	20240608_691bc5ca-5d5e-60c2-e053-2991aa0abb93.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Spironolactone	SPIRONOLACTONE	PD-Rx Pharmaceuticals, Inc.	3487305c-25a6-4e82-923c-3e4dd638c988	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203512 application number: ANDA203512
Spironolactone	SPIRONOLACTONE	Bryant Ranch Prepack	473dc80f-11b7-46bf-b0b4-7a271444fca2	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203512 application number: ANDA203512
Spironolactone	SPIRONOLACTONE	PD-Rx Pharmaceuticals, Inc.	c223a334-7383-429f-b8e3-a21200f16962	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203512 application number: ANDA203512
Spironolactone	SPIRONOLACTONE	Bryant Ranch Prepack	2ed347bc-a9f1-4800-99bc-9af9912ead1f	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203512 application number: ANDA203512
Spironolactone	SPIRONOLACTONE	Bryant Ranch Prepack	650bf1c1-b7f1-4e5b-a9f0-3a2e31b98dd3	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203512 application number: ANDA203512
Spironolactone	SPIRONOLACTONE	Northwind Health Company, LLC	ab3090fc-458c-17c1-e053-2995a90a6ffa	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203512 application number: ANDA203512
Spironolactone	SPIRONOLACTONE	Accord Healthcare, Inc.	8a96e2c9-049a-43ab-abf3-21baedeb736f	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203512 application number: ANDA203512
Spironolactone	SPIRONOLACTONE	PD-Rx Pharmaceuticals, Inc.	c0efa529-2870-4260-b604-2f30e2cbb87b	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203512 application number: ANDA203512
Spironolactone	SPIRONOLACTONE	NuCare Pharmaceuticals, Inc.	540ee876-78fb-1792-e054-00144ff88e88	2024-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203512 application number: ANDA203512
Spironolactone	SPIRONOLACTONE	NuCare Pharmaceuticals,Inc.	691bc5ca-5d5e-60c2-e053-2991aa0abb93	2024-06-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203512 application number: ANDA203512 ndc (product): 68071-4374
Spironolactone	SPIRONOLACTONE	Asclemed USA, Inc.	31c42b3e-f076-49d9-aa61-6cef0dbb5543	2023-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203512 application number: ANDA203512
Spironolactone	SPIRONOLACTONE	Proficient Rx LP	dffac5dc-a111-4095-a96c-54cc5c3866e5	2023-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203512 application number: ANDA203512
Spironolactone	SPIRONOLACTONE	A-S Medication Solutions	791251af-d276-40fc-8c35-9d179b20e219	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203512 application number: ANDA203512
Spironolactone	SPIRONOLACTONE	Aphena Pharma Solutions - Tennessee, LLC	f230f1fa-878e-4753-a16c-bf059b59cdef	2017-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203512 application number: ANDA203512

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
198223	spironolactone 50 MG Oral Tablet	PSN	691bc5ca-5d5e-60c2-e053-2991aa0abb93	5
198223	spironolactone 50 MG Oral Tablet	SCD	691bc5ca-5d5e-60c2-e053-2991aa0abb93	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-4374-3	68071437403	30 TABLET, FILM COATED in 1 BOTTLE (68071-4374-3)	2018-04-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Spironolactone tablets, USP	NuCare Pharmaceuticals,Inc.	2024-06-07	HUMAN PRESCRIPTION DRUG LABEL	5