Hydralazine Hydrochloride

Product NDC: 55154-2083
Requested package NDC: 55154-2083-0
11-digit product format: 551542083
Labeler code: 55154
Product ID: 55154-2083_76c05e84-b54b-4a61-8f62-fe944599c17f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydralazine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA086242
Marketing category: ANDA
Marketing start: 2008-03-18
Marketing end: 0000-00-00
Substance: HYDRALAZINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55154-2083	55154-2083-0	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 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`

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

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	RLD / RS	Approval date
A086242-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2010-02-04
A086242-002	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982
A086242-003	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982
A086242-004	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL		2010-02-04

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 · 164 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
2026-02-19 14:30 UTC	2026-02	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 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	A086242-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086242-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086242-003	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086242-004	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086242-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086242-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086242-003	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086242-004	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086242-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086242-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086242-003	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086242-004	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086242-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086242-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086242-003	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086242-004	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086242-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086242-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086242-003	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086242-004	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086242-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086242-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086242-003	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086242-004	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086242-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086242-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086242-003	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086242-004	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086242-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086242-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086242-003	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086242-004	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086242-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086242-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086242-003	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086242-004	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086242-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A086242-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A086242-003	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A086242-004	AA	1	`d06236e962d9…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDRALAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	6
HYDRALAZINE	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	6
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	6
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	6
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]	6

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	4671cefa-4468-4116-ba40-3d3b0f581ea1	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086242 application number: ANDA086242
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	db138daf-2d2d-4730-a621-a1bd209d5b9f	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086242 application number: ANDA086242
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	a04eefaf-ba3c-448d-8ece-4aa9ab2e3508	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086242 application number: ANDA086242
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	e9450e82-329f-4fd8-a0b3-3e8e22715965	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086242 application number: ANDA086242
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Northwind Health Company, LLC	ab1c6f37-3b64-23fb-e053-2995a90a932f	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086242 application number: ANDA086242
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Northwind Health Company, LLC	ada28f78-e933-7acf-e053-2995a90ae316	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086242 application number: ANDA086242
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Chartwell RX, LLC	0c7f9bd0-6c0a-4521-b77a-3582faa96874	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086242 application number: ANDA086242
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Proficient Rx LP	63f388e0-9f3d-4902-990c-9a105aa098ad	2020-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086242 application number: ANDA086242

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	Marketing end	Sample	Exclude flag	Status
55154-2083-0	55154208300	10 BLISTER PACK in 1 BAG (55154-2083-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2008-03-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydralazine Hydrochloride Tablets, USP	Cardinal Health 107, LLC	2022-12-20	HUMAN PRESCRIPTION DRUG LABEL	12