Spironolactone

Product NDC: 70518-3721
Requested package NDC: 70518-3721-3
11-digit product format: 705183721
Labeler code: 70518
Product ID: 70518-3721_4f80edc6-df4e-bc19-e063-6294a90ada37
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 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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (package): 70518-3721-3 ndc (product): 70518-3721 ndc11 (package): 70518372103
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

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

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	Units	Marketing start	Sample	Exclude flag	Status
70518-3721-3	70518372103	100 POUCH in 1 BOX (70518-3721-3) / 1 TABLET, COATED in 1 POUCH (70518-3721-4)	100 pouch	2026-01-28	No	No	Current