Hydralazine Hydrochloride

Product NDC: 55154-0287
11-digit product format: 551540287
Labeler code: 55154
Product ID: 55154-0287_7dc89d53-ade0-40de-b7e3-d14f7151958d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydralazine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA088468
Marketing category: ANDA
Marketing start: 2026-09-14
Substance: HYDRALAZINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A088468-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A088468-001	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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	1984-05-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	1984-05-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	1984-05-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	1984-05-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	1984-05-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	1984-05-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	1984-05-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	1984-05-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A088468-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088468-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088468-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088468-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088468-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088468-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088468-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088468-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088468-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088468-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088468-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088468-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088468-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088468-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088468-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088468-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088468-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088468-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088468-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088468-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088468-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088468-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088468-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088468-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088468-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088468-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088468-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088468-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088468-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088468-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088468-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088468-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088468-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088468-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088468-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088468-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088468-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088468-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088468-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088468-001	AA	1	`f41ea6bd6efb…`

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: Hydralazine Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDRALAZINE HYDROCHLORIDE	50 mg/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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Cardinal Health 107, LLC	db7500f3-f8a6-46b1-bb64-9727617a9643	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088468 application number: ANDA088468
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Safecor Health, LLC	66c5eaa4-a51a-464b-98ad-f094f32876dd	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088468 application number: ANDA088468
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Mylan Institutional Inc.	493a8b7e-5bb1-4db2-91a7-77ed87864131	2025-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088468 application number: ANDA088468
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	A-S Medication Solutions	e617023e-b060-4db9-a97e-e2b11a37901e	2023-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088468 application number: ANDA088468
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	ddbbdb09-3202-42d7-bbb0-08331dde2f54	2016-02-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088468 application number: ANDA088468

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FD171B778Y	HYDRALAZINE HYDROCHLORIDE	304-20-1	HYDRALAZINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55154-0287-0	55154028700	10 BLISTER PACK in 1 BAG (55154-0287-0) / 1 TABLET in 1 BLISTER PACK	10 blister pack	2026-09-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HydrALAZINE Hydrochloride Tablets USP	Cardinal Health 107, LLC	2026-09-14	HUMAN PRESCRIPTION DRUG LABEL	1