Hydralazine Hydrochloride

Product NDC: 55154-0187
11-digit product format: 551540187
Labeler code: 55154
Product ID: 55154-0187_6d2e05d1-0c58-4aea-9f93-e67ea66e31e1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydralazine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA040858
Marketing category: ANDA
Marketing start: 2025-07-09
Substance: HYDRALAZINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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	TE codes	Approval date
A040858-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2010-02-26
A040858-002	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-02-26
A040858-003	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-02-26
A040858-004	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2010-02-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040858-001	AA
A040858-002	AA
A040858-003	AA
A040858-004	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 · 164 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
2026-02-19 14:30 UTC	2026-02	A040858-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2010-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040858-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040858-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040858-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2010-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040858-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2010-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040858-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040858-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040858-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2010-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040858-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2010-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040858-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040858-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040858-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2010-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040858-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2010-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040858-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040858-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040858-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2010-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040858-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2010-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040858-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040858-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040858-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2010-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040858-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2010-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040858-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040858-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040858-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2010-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040858-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2010-02-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040858-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-02-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040858-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-02-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040858-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2010-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040858-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2010-02-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040858-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-02-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040858-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-02-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040858-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2010-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040858-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2010-02-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040858-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-02-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040858-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-02-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040858-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2010-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040858-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2010-02-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040858-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-02-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040858-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2010-02-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040858-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2010-02-26	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 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	A040858-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040858-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040858-003	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040858-004	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040858-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040858-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040858-003	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040858-004	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040858-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040858-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040858-003	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040858-004	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040858-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040858-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040858-003	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040858-004	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040858-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040858-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040858-003	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040858-004	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040858-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040858-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040858-003	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040858-004	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040858-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040858-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040858-003	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040858-004	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040858-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040858-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040858-003	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040858-004	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040858-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040858-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040858-003	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040858-004	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040858-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040858-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040858-003	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040858-004	AA	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Hydralazine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDRALAZINE HYDROCHLORIDE	50 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
905225	Internal RxNorm lookup
905395	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
336b11da-e592-4386-921f-3c136d754f2a	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
55154-0187-0	Hydralazine Hydrochloride	10 in 1 BAG	TABLET	10		3
55154-0187-0	Hydralazine Hydrochloride	1 in 1 BLISTER PACK	TABLET	1		3

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Major Pharmaceuticals	b6ccd35e-f69c-4eef-a456-905e030ae911	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040858 application number: ANDA040858
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Northwind Health Company, LLC	1275dd50-d97f-2e8f-e063-6394a90a4a67	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040858 application number: ANDA040858
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	d61ffa06-8138-4a1d-9530-095a80d9c9ce	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040858 application number: ANDA040858
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	a70d20d6-23f0-477e-915c-678a86782175	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040858 application number: ANDA040858
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Cardinal Health 107, LLC	a1066707-2391-4918-8ded-600c017fde48	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040858 application number: ANDA040858
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	669532c9-ba15-4f4b-95a8-13782deb3521	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040858 application number: ANDA040858
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	6c40d818-77a9-492c-b9b6-d8a0fe8d6736	2026-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040858 application number: ANDA040858
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Cardinal Health 107, LLC	336b11da-e592-4386-921f-3c136d754f2a	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040858 application number: ANDA040858 ndc (product): 55154-0187
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Proficient Rx LP	024ac6b8-5ce0-4435-9b11-b1806c511d7b	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040858 application number: ANDA040858
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	51c293c1-70e7-48c7-8af1-a8b74312ed56	2025-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040858 application number: ANDA040858
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Coupler LLC	2e9688ef-781c-aead-e063-6294a90a7bca	2025-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040858 application number: ANDA040858
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	American Health Packaging	2e82655e-8435-46fa-b734-8e7c6e803453	2024-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040858 application number: ANDA040858

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	336b11da-e592-4386-921f-3c136d754f2a	3
905395	hydrALAZINE HCl 50 MG Oral Tablet	PSN	336b11da-e592-4386-921f-3c136d754f2a	3
905225	hydralazine hydrochloride 25 MG Oral Tablet	SCD	336b11da-e592-4386-921f-3c136d754f2a	3
905395	hydralazine hydrochloride 50 MG Oral Tablet	SCD	336b11da-e592-4386-921f-3c136d754f2a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55154-0187-0	55154018700	10 BLISTER PACK in 1 BAG (55154-0187-0) / 1 TABLET in 1 BLISTER PACK	10 blister pack	2025-07-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDRALAZINE HYDROCHLORIDE TABLETS, USP	Cardinal Health 107, LLC	2025-11-06	HUMAN PRESCRIPTION DRUG LABEL	3