Application 040750

Type: ANDA
Sponsor: OXFORD PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SPIRONOLACTONE	SPIRONOLACTONE	TABLET;ORAL	25MG	No	No
002	SPIRONOLACTONE	SPIRONOLACTONE	TABLET;ORAL	50MG	No	No
003	SPIRONOLACTONE	SPIRONOLACTONE	TABLET;ORAL	100MG	No	No

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#

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	PD-Rx Pharmaceuticals, Inc.	73564b3d-8ede-4008-b75c-1277153b5bb6	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040750 application number: ANDA040750 ndc (product): 72789-290
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 ndc (product): 72789-291
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 ndc (product): 72789-292
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
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 ndc (product): 69584-854 ndc (product): 69584-853 ndc (product): 69584-852
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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-5763	Spironolactone	spironolactone	Par Pharmaceutical	ANDA	Current
0603-5763	Spironolactone	spironolactone	Par Pharmaceutical	ANDA	Current
0603-5764	Spironolactone	spironolactone	Par Pharmaceutical	ANDA	Current
0603-5764	Spironolactone	spironolactone	Par Pharmaceutical	ANDA	Current
0603-5765	Spironolactone	spironolactone	Par Pharmaceutical	ANDA	Current
0603-5765	Spironolactone	spironolactone	Par Pharmaceutical	ANDA	Current
0615-8031	Spironolactone	spironolactone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
21695-960	Spironolactone	spironolactone	Rebel Distributors Corp	ANDA	Current
33261-764	Spironolactone	spironolactone	Aidarex Pharmaceuticals LLC	ANDA	Current
33261-869	Spironolactone	spironolactone	Aidarex Pharmaceuticals LLC	ANDA	Current
33261-895	Spironolactone	spironolactone	Aidarex Pharmaceuticals LLC	ANDA	Current
43063-802	Spironolactone	spironolactone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-802	Spironolactone	spironolactone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43353-239	Spironolactone	spironolactone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-2312	Spironolactone	spironolactone	A-S Medication Solutions	ANDA	Current
53808-0338	Spironolactone	spironolactone	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0592	Spironolactone	spironolactone	State of Florida DOH Central Pharmacy	ANDA	Current
63187-634	Spironolactone	spironolactone	Proficient Rx LP	ANDA	Current
63187-634	Spironolactone	spironolactone	Proficient Rx LP	ANDA	Current
66336-916	Spironolactone	spironolactone	Dispensing Solutions, Inc.	ANDA	Current
68084-206	Spironolactone	spironolactone	American Health Packaging	ANDA	Current
68084-207	Spironolactone	spironolactone	American Health Packaging	ANDA	Current
68084-208	Spironolactone	spironolactone	American Health Packaging	ANDA	Current
69584-852	Spironolactone	Spironolactone	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-853	Spironolactone	Spironolactone	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-854	Spironolactone	Spironolactone	Oxford Pharmaceuticals, LLC	ANDA	Current
72789-290	Spironolactone	Spironolactone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-290	Spironolactone	Spironolactone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-291	Spironolactone	Spironolactone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-292	Spironolactone	Spironolactone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current