HYDRALAZINE HYDROCHLORIDE

Product NDC: 55801-113
11-digit product format: 558010113
Labeler code: 55801
Product ID: 55801-113_a2faa2ce-2e89-44f7-8c7a-b003d285c758
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYDRALAZINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Appco Pharma LLC
Application: ANDA209251
Marketing category: ANDA
Marketing start: 2018-10-05
Marketing end: 0000-00-00
Substance: HYDRALAZINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A209251-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-07-09
A209251-002	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2018-07-09
A209251-003	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2018-07-09
A209251-004	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2018-07-09

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 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A209251-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209251-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2018-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209251-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2018-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209251-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2018-07-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209251-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209251-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2018-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209251-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2018-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209251-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2018-07-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209251-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209251-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2018-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209251-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2018-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209251-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2018-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209251-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209251-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2018-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209251-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2018-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209251-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2018-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209251-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209251-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2018-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209251-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2018-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209251-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2018-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209251-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209251-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2018-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209251-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2018-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209251-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2018-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209251-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209251-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2018-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209251-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2018-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209251-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2018-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209251-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209251-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2018-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209251-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2018-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209251-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2018-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209251-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209251-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2018-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209251-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2018-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209251-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2018-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209251-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209251-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2018-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209251-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2018-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209251-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2018-07-09	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A209251-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209251-002	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209251-003	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209251-004	AA	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209251-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209251-002	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209251-003	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209251-004	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209251-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209251-002	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209251-003	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209251-004	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209251-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209251-002	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209251-003	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209251-004	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209251-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209251-002	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209251-003	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209251-004	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209251-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209251-002	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209251-003	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209251-004	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209251-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209251-002	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209251-003	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209251-004	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209251-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209251-002	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209251-003	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209251-004	AA	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDRALAZINE HYDROCHLORIDE TABLETS USP	Appco Pharma LLC \| Upsher-Smith Laboratories, LLC	2018-12-18	Human Prescription Drug Label	7

HYDRALAZINE HYDROCHLORIDE

Orange Book products#

Observed Orange Book product history#

Observed Orange Book normalized TE history#

Reported adverse events (FAERS/openFDA)#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#