Hydralazine Hydrochloride

Product NDC: 50090-2514
Requested package NDC: 50090-2514-1
11-digit product format: 500902514
Labeler code: 50090
Product ID: 50090-2514_7459b02f-b856-4754-9254-6635f12e8109
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydralazine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA088468
Marketing category: ANDA
Marketing start: 1990-09-30
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: 2022-12-31
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	50090-2514	50090-2514-1	I	Inactivated by FDA		2026-08-07

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 · 15 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…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A088468-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A088468-001	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 2 · 41 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	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	1984-05-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	1984-05-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	1984-05-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	1984-05-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	1984-05-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	1984-05-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	1984-05-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	1984-05-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A088468-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088468-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088468-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088468-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088468-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088468-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088468-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088468-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088468-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088468-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088468-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088468-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088468-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088468-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088468-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088468-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088468-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088468-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088468-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088468-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088468-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088468-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088468-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088468-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088468-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088468-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088468-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088468-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088468-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088468-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088468-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088468-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088468-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088468-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088468-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088468-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088468-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088468-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088468-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088468-001	AA	1	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-2514-1	2023-01-30	HydrALAZINE Hydrochloride Tablets USP
50090-2514-2	2023-01-30	HydrALAZINE Hydrochloride Tablets USP
50090-2514-1	2020-05-14	HydrALAZINE Hydrochloride Tablets USP
50090-2514-2	2020-05-14	HydrALAZINE Hydrochloride Tablets USP
50090-2514-1	2020-01-31	HydrALAZINE Hydrochloride Tablets USP
50090-2514-2	2020-01-31	HydrALAZINE Hydrochloride Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-2514-1	Hydralazine Hydrochloride	60 in 1 BOTTLE	TABLET	60		18
50090-2514-2	Hydralazine Hydrochloride	180 in 1 BOTTLE	TABLET	180		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-2514-1	EA - Each	50090-2514	7fb40edf-5cbe-4d75-a7c3-2abc79d026e0	1	2018-11-06
50090-2514-2	EA - Each	50090-2514	36231816-db66-484d-9cd0-5a91624c7629	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-2514	HYDRALAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]	18	Legacy NDC, 2 package rows	20210416_f8a1b91c-ed4e-4fb4-b1c3-3d5a806fa501.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Safecor Health, LLC	66c5eaa4-a51a-464b-98ad-f094f32876dd	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088468 application number: ANDA088468
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Cardinal Health 107, LLC	db7500f3-f8a6-46b1-bb64-9727617a9643	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088468 application number: ANDA088468
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Mylan Institutional Inc.	493a8b7e-5bb1-4db2-91a7-77ed87864131	2025-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088468 application number: ANDA088468
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	A-S Medication Solutions	e617023e-b060-4db9-a97e-e2b11a37901e	2023-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088468 application number: ANDA088468
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	ddbbdb09-3202-42d7-bbb0-08331dde2f54	2016-02-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088468 application number: ANDA088468

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
905395	hydrALAZINE HCl 50 MG Oral Tablet	PSN	f8a1b91c-ed4e-4fb4-b1c3-3d5a806fa501	18
905395	hydralazine hydrochloride 50 MG Oral Tablet	SCD	f8a1b91c-ed4e-4fb4-b1c3-3d5a806fa501	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-2514-1	50090251401	60 TABLET in 1 BOTTLE (50090-2514-1)	60 tablet	2017-02-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HydrALAZINE Hydrochloride Tablets USP	A-S Medication Solutions	2021-04-15	HUMAN PRESCRIPTION DRUG LABEL	18