HYDRALAZINE HYDROCHLORIDE

Product NDC: 55289-133
Requested package NDC: 55289-133-60
11-digit product format: 552890133
Labeler code: 55289
Product ID: 55289-133_47e36800-0665-cf64-e063-6294a90a85af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydralazine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA086242
Marketing category: ANDA
Marketing start: 2007-04-06
Marketing end: 2026-08-31
Substance: HYDRALAZINE HYDROCHLORIDE
Active strength: 25 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 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: HYDRALAZINE HYDROCHLORIDE

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDRALAZINE HYDROCHLORIDE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
FD171B778Y	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
905225	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4671cefa-4468-4116-ba40-3d3b0f581ea1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a3137695-e199-b3b3-2950-87a8ac429689	Product name	5	20260316
e9ed2ee5-d109-4795-bffe-c3b047717749	Product name	2	20250107
0284f4a6-db58-dacf-18fe-da73f4aeea88	Product name	4	20180827
0ad8bdca-888e-00da-648b-6a4de854a167	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55289-133-60	HYDRALAZINE HYDROCHLORIDE	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55289-133-60	EA - Each	55289-133	46c9eacc-cf13-45ab-b755-1d3d9113a831	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55289-133	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	15	Current NDC, Legacy NDC, 1 package rows	20240312_4671cefa-4468-4116-ba40-3d3b0f581ea1.zip

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 ndc (package): 55289-133-60 ndc (product): 55289-133 ndc11 (package): 55289013360
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
905225	hydrALAZINE HCl 25 MG Oral Tablet	PSN	4671cefa-4468-4116-ba40-3d3b0f581ea1	17
905225	hydralazine hydrochloride 25 MG Oral Tablet	SCD	4671cefa-4468-4116-ba40-3d3b0f581ea1	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55289-133-60	55289013360	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-133-60)	2022-06-24	0000-00-00	No	No	Current