Hydralazine Hydrochloride

Product NDC: 35356-944
11-digit product format: 353560944
Labeler code: 35356
Product ID: 35356-944_aecda0b9-bc01-49be-b631-ea7d074c2560
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydralazine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Lake Erie Medical DBA Quality Care Products LLC
Application: ANDA090527
Marketing category: ANDA
Marketing start: 2009-06-01
Marketing end: 0000-00-00
Substance: HYDRALAZINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	35356-944		D	Discontinued by firm	2026-10-15
excluded package	package	35356-944	35356-944-30	D	Discontinued by firm	2026-10-15
excluded package	package	35356-944	35356-944-60	D	Discontinued by firm	2026-10-15
excluded package	package	35356-944	35356-944-90	D	Discontinued by firm	2026-10-15

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 · 48 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	35356-944-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35356-944-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35356-944-60	`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	35356-944-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35356-944-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35356-944-60	`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	35356-944-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35356-944-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35356-944-60	`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	35356-944-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35356-944-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35356-944-60	`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	35356-944-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35356-944-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35356-944-60	`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	35356-944-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35356-944-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35356-944-60	`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	35356-944-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35356-944-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35356-944-60	`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	35356-944-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	35356-944-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	35356-944-60	`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	35356-944-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	35356-944-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	35356-944-60	`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	35356-944-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	35356-944-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	35356-944-60	`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	35356-944-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	35356-944-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	35356-944-60	`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	35356-944-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	35356-944-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	35356-944-60	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090527-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29
A090527-002	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29
A090527-003	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29
A090527-004	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A090527-001	AA
A090527-002	AA
A090527-003	AA
A090527-004	AA

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 5 · 176 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
2026-10-15 13:18:30	2026-09	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 5 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A090527-001	AA	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090527-002	AA	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090527-003	AA	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090527-004	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090527-001	AA	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A090527-002	AA	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A090527-003	AA	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A090527-004	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090527-001	AA	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090527-002	AA	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090527-003	AA	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090527-004	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090527-001	AA	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090527-002	AA	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090527-003	AA	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090527-004	AA	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
35356-944-60	EA - Each	35356-944	0568ee3a-32ed-4f1a-a1b8-c6ba574500e6	1	2013-09-04

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	37ba0233-ed75-498a-a067-6220da573653	2024-05-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090527 application number: ANDA090527