Spironolactone and Hydrochlorothiazide

Product NDC: 0378-0141
11-digit product format: 003780141
Labeler code: 0378
Product ID: 0378-0141_44957b79-6f3a-48b0-b985-060aaa923bfd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: spironolactone and hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA086513
Marketing category: ANDA
Marketing start: 2012-07-26
Marketing end: 2020-02-29
Substance: SPIRONOLACTONE; HYDROCHLOROTHIAZIDE
Active strength: 25 mg/1; mg/1
Pharmacologic classes: Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0378-0141		D	Discontinued by firm	2026-08-11
excluded package	package	0378-0141	0378-0141-01	D	Discontinued by firm	2026-08-11
excluded package	package	0378-0141	0378-0141-05	D	Discontinued by firm	2026-08-11

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 · 36 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-0141-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-0141-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-0141-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-0141-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-0141-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-0141-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-0141-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-0141-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-0141-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-0141-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-0141-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-0141-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-0141-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-0141-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-0141-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-0141-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-0141-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-0141-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-0141-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-0141-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-0141-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-0141-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-0141-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-0141-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; SPIRONOLACTONE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A086513-001	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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086513-001	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	25MG;25MG	TABLET / ORAL	AB	Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A086513-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086513-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086513-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086513-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086513-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086513-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086513-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086513-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086513-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086513-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086513-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086513-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086513-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086513-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086513-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086513-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086513-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086513-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086513-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086513-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086513-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086513-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086513-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086513-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086513-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086513-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086513-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086513-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086513-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086513-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086513-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086513-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086513-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086513-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086513-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086513-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086513-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086513-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086513-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086513-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
1199f4b7-b537-466c-9a1c-cb09131e9f8b	Product name	1	20251117
d335cba1-5b36-51c8-120a-594ec9d05330	Product name	5	20251114
e1a63b6e-1877-c2c1-01a3-03ea2817aa6f	Product name	3	20251027
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
25f5e2cf-3572-477b-994c-aa692751e5a8	Product name	2	20250616
96816964-c075-ffa7-b7b8-d8570411a3b9	Product name	7	20250305
162cbc9d-ecc3-72ba-af9f-c76e2756ef54	Product name	3	20221207
9b303cd4-3186-2454-5706-3137e8b2dfd2	Product name	4	20221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0ea	Product name	1	20200505
a8e65197-7914-7acf-c7ec-914d53819b34	Product name	3	20190624
8b67f333-47d1-8464-7ce4-406d3dbb295f	Product name	7	20190618
89a57420-ab44-5323-14f9-595159145f9b	Product name	2	20190612
c27b049d-3258-48cf-ebe5-08c236ae78e2	Product name	3	20190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058	Product name	4	20180613
15b375b1-89c7-9594-80df-5a8c8864aee0	Product name	3	20180108
a7349398-661d-d9fc-46df-7e128bbd61d9	Product name	5	20171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d	Product name	2	20170719
e0eeb018-194e-4b70-a57d-bac47a97b8ea	Product name	1	20160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502	Product name	2	20150320
ea069444-e874-4c28-833f-d2f52734ef4d	Product name	1	20150206
041df61b-f8b6-48a6-7b67-411e1412678b	Product name	1	20140508
0ad8bdca-888e-00da-648b-6a4de854a167	Product name	1	20140508
433a3439-b8f3-d13a-d2c8-9b221d628d60	Product name	1	20140508
59212689-39e5-a976-6d21-882d76d8079a	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508
78637fb0-95c8-441f-e4b4-db1274b6f956	Product name	1	20140508
df89bd47-2db4-d593-ab37-d11953fd5536	Product name	1	20140508
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-0141-01	EA - Each	0378-0141	86d4a771-4c18-4d8f-9e45-3189959dbed5	1	2012-07-24
0378-0141-05	EA - Each	0378-0141	4a1eb5e3-7619-4b19-90a7-64d6075dfe07	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
SPIRONOLACTONE	ACTIVE INGREDIENT	27O7W4T232	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
SPIRONOLACTONE	ACTIVE MOIETY	27O7W4T232	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
SPIRONOLACTONE	ACTIVE INGREDIENT	27O7W4T232	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
SPIRONOLACTONE	ACTIVE MOIETY	27O7W4T232	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Spironolactone and Hydrochlorothiazide	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	Safecor Health LLC	6fa96947-f4d8-4ca4-98fd-a2c123310d83	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086513 application number: ANDA086513
Spironolactone and Hydrochlorothiazide	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	Mylan Pharmaceuticals Inc.	0c8c973f-13a2-4883-8316-4006398e2931	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086513 application number: ANDA086513
Spironolactone and Hydrochlorothiazide	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	Mylan Institutional Inc.	f2a4fbc0-650b-440d-9555-c1720fe0fe35	2025-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086513 application number: ANDA086513

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
27O7W4T232	SPIRONOLACTONE	52-01-7	SPIRONOLACTONE
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198224	spironolactone 25 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	45745495-d53f-4c52-909e-ef12ac437733	1
198224	hydrochlorothiazide 25 MG / spironolactone 25 MG Oral Tablet	SCD	45745495-d53f-4c52-909e-ef12ac437733	1
198224	HCTZ 25 MG / spironolactone 25 MG Oral Tablet	SY	45745495-d53f-4c52-909e-ef12ac437733	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Spironolactone and Hydrochlorothiazide - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2015-05-07	HUMAN PRESCRIPTION DRUG LABEL	6
Spironolactone and Hydrochlorothiazide - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2010-06-01	HUMAN PRESCRIPTION DRUG LABEL	1