Spironolactone

Product NDC: 70518-3721
Requested package NDC: 70518-3721-2
11-digit product format: 705183721
Labeler code: 70518
Product ID: 70518-3721_593e6922-1a96-0bf6-e063-6294a90aa9b4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Spironolactone
Dosage form: TABLET, COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA040750
Marketing category: ANDA
Marketing start: 2023-04-24
Substance: SPIRONOLACTONE
Active strength: 100 mg/1
Pharmacologic classes: Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 129 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
2026-09-14 22:38:34	2026-08	A040750-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2006-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040750-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2006-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040750-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2006-08-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040750-001	SPIRONOLACTONE	25MG	TABLET / ORAL	AB	2006-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040750-002	SPIRONOLACTONE	50MG	TABLET / ORAL	AB	2006-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040750-003	SPIRONOLACTONE	100MG	TABLET / ORAL	AB	2006-08-29	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040750-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040750-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040750-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040750-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040750-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040750-003	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SPIRONOLACTONE	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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198222	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
7646ca22-710e-4a5c-9613-b829e2f9d5ce	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70518-3721-0	Spironolactone	30 in 1 BLISTER PACK	TABLET, COATED	30	8
70518-3721-1	Spironolactone	90 in 1 BOTTLE, PLASTIC	TABLET, COATED	90	8
70518-3721-2	Spironolactone	30 in 1 BOTTLE, PLASTIC	TABLET, COATED	30	8
70518-3721-3	Spironolactone	100 in 1 BOX	TABLET, COATED	100	8
70518-3721-4	Spironolactone	1 in 1 POUCH	TABLET, COATED	1	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3721	SPIRONOLACTONE TABLET, COATED [REMEDYREPACK INC.]	4	Current NDC, 5 package rows	20241127_7646ca22-710e-4a5c-9613-b829e2f9d5ce.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 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Spironolactone	SPIRONOLACTONE	Preferred Pharmaceuticals Inc.	5e456f3c-f93e-41c6-80c5-a737ed70feda	2026-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040750 application number: ANDA040750
Spironolactone	SPIRONOLACTONE	Preferred Pharmaceuticals Inc.	4290b3ec-8993-47d4-bfe3-fcb81d7baed8	2026-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040750 application number: ANDA040750
Spironolactone	SPIRONOLACTONE	REMEDYREPACK INC.	7646ca22-710e-4a5c-9613-b829e2f9d5ce	2026-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040750 application number: ANDA040750 ndc (package): 70518-3721-2 ndc (product): 70518-3721 ndc11 (package): 70518372102
Spironolactone	SPIRONOLACTONE	REMEDYREPACK INC.	b119ed8a-289a-46c5-9778-6b07e4c061c4	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040750 application number: ANDA040750
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	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	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

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	7646ca22-710e-4a5c-9613-b829e2f9d5ce	8
198222	spironolactone 100 MG Oral Tablet	SCD	7646ca22-710e-4a5c-9613-b829e2f9d5ce	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70518-3721-2	70518372102	30 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-3721-2)	2025-08-27	No	No	Current