Hydralazine Hydrochloride

Product NDC: 70518-2551
11-digit product format: 705182551
Labeler code: 70518
Product ID: 70518-2551_4a67249e-ac1c-3ea4-e063-6394a90a3fc5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydralazine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA040901
Marketing category: ANDA
Marketing start: 2020-01-22
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

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, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-2551-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-2551-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-2551-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-2551-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-2551-0	`367a005e9d99…`	`383a685ebd0f…`

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
A040901-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2008-09-12
A040901-002	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2008-09-12
A040901-003	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2008-09-12
A040901-004	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2008-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040901-001	AA
A040901-002	AA
A040901-003	AA
A040901-004	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	A040901-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2008-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040901-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2008-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040901-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2008-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040901-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2008-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040901-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2008-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040901-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2008-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040901-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2008-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040901-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2008-09-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040901-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2008-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040901-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2008-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040901-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2008-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040901-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2008-09-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040901-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2008-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040901-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2008-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040901-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2008-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040901-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2008-09-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040901-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2008-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040901-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2008-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040901-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2008-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040901-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2008-09-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040901-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2008-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040901-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2008-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040901-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2008-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040901-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2008-09-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040901-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2008-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040901-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2008-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040901-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2008-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040901-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2008-09-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040901-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2008-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040901-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2008-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040901-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2008-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040901-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2008-09-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040901-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2008-09-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040901-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2008-09-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040901-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2008-09-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040901-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2008-09-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040901-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2008-09-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040901-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2008-09-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040901-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2008-09-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040901-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2008-09-12	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A040901-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040901-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040901-003	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040901-004	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040901-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040901-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040901-003	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040901-004	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040901-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040901-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040901-003	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040901-004	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040901-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040901-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040901-003	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040901-004	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040901-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040901-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040901-003	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040901-004	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040901-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040901-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040901-003	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040901-004	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040901-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040901-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040901-003	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040901-004	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040901-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040901-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040901-003	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040901-004	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040901-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040901-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040901-003	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040901-004	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040901-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040901-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040901-003	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040901-004	AA	1	`d06236e962d9…`

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	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
89afc8ef-27c4-489a-81de-3f8f65f6bbb8	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	SPL version
70518-2551-0	Hydralazine Hydrochloride	30 in 1 BLISTER PACK	TABLET	30	13
70518-2551-1	Hydralazine Hydrochloride	30 in 1 BLISTER PACK	TABLET	30	13
70518-2551-2	Hydralazine Hydrochloride	180 in 1 BOTTLE, PLASTIC	TABLET	180	13
70518-2551-3	Hydralazine Hydrochloride	90 in 1 BOTTLE, PLASTIC	TABLET	90	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-2551	HYDRALAZINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]	9	Current NDC, Legacy NDC, 4 package rows	20250501_89afc8ef-27c4-489a-81de-3f8f65f6bbb8.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	438479d0-ff61-4008-a0fc-1ee44b97cf7f	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040901 application number: ANDA040901
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	89afc8ef-27c4-489a-81de-3f8f65f6bbb8	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040901 application number: ANDA040901 ndc (product): 70518-2551
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	A-S Medication Solutions	7253aaa0-e272-499f-9bfa-304e9556a8fb	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040901 application number: ANDA040901
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	A-S Medication Solutions	f16f1d87-f9e6-4555-9baf-26ff17cb1d28	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040901 application number: ANDA040901
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	d2d98842-ff32-4a61-94e0-60e06919948f	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040901 application number: ANDA040901
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	a79ddc89-546b-4808-879d-c0f592141636	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040901 application number: ANDA040901
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	90c18c55-3045-4a10-a2bb-012e4a5e1564	2025-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040901 application number: ANDA040901
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	5da36930-d3da-4b5c-9e22-2b141bc01a9c	2025-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040901 application number: ANDA040901
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Proficient Rx LP	775e99c4-e18d-4648-a0e3-8709950249ff	2025-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040901 application number: ANDA040901
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	a862321d-ebc1-7676-e053-2995a90a5861	2024-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040901 application number: ANDA040901
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	f07abdec-6d94-45b6-be1b-10a898ea28c2	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040901 application number: ANDA040901
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	3b61d1b0-c699-67a8-e054-00144ff88e88	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040901 application number: ANDA040901
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4b7d3378-86f8-0a5f-e054-00144ff8d46c	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040901 application number: ANDA040901
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Proficient Rx LP	48cf71dd-19dc-4239-9117-ebcf9731a45d	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040901 application number: ANDA040901

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	89afc8ef-27c4-489a-81de-3f8f65f6bbb8	13
905225	hydralazine hydrochloride 25 MG Oral Tablet	SCD	89afc8ef-27c4-489a-81de-3f8f65f6bbb8	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2551-0	70518255100	30 TABLET in 1 BLISTER PACK (70518-2551-0)	30 tablet	2020-01-22	0000-00-00	No	No	Current
70518-2551-1	70518255101	30 TABLET in 1 BLISTER PACK (70518-2551-1)	30 tablet	2025-07-31		No	No	Current
70518-2551-2	70518255102	180 TABLET in 1 BOTTLE, PLASTIC (70518-2551-2)	180 tablet	2025-09-04		No	No	Current
70518-2551-3	70518255103	90 TABLET in 1 BOTTLE, PLASTIC (70518-2551-3)	90 tablet	2025-09-04		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDRALAZINE HYDROCHLORIDE TABLETS, USP	REMEDYREPACK INC.	2026-02-09	HUMAN PRESCRIPTION DRUG LABEL	13