Hydralazine Hydrochloride

Product NDC: 48433-046
11-digit product format: 484330046
Labeler code: 48433
Product ID: 48433-046_4cc62699-816e-6056-e063-6394a90a36a7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydralazine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Safecor Health, LLC
Application: ANDA089097
Marketing category: ANDA
Marketing start: 2026-03-06
Substance: HYDRALAZINE HYDROCHLORIDE
Active strength: 10 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A089097-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089097-001	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	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089097-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	1985-12-18	`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	A089097-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089097-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089097-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089097-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089097-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089097-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089097-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089097-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089097-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089097-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089097-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089097-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089097-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089097-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089097-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089097-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089097-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089097-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089097-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089097-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089097-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089097-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089097-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089097-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089097-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089097-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089097-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089097-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089097-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089097-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089097-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089097-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089097-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089097-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089097-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089097-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089097-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089097-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089097-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089097-001	AA	1	`cb3db0bc1861…`

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	10 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
905199	Internal RxNorm lookup
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
66c5eaa4-a51a-464b-98ad-f094f32876dd	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
48433-046-01	Hydralazine Hydrochloride	1 in 1 BLISTER PACK	TABLET	1		2
48433-046-20	Hydralazine Hydrochloride	100 in 1 CARTON	TABLET	100		2

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 · 3 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): 089097 application number: ANDA089097 ndc (product): 48433-046
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Mylan Institutional Inc.	493a8b7e-5bb1-4db2-91a7-77ed87864131	2025-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089097 application number: ANDA089097
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	ddbbdb09-3202-42d7-bbb0-08331dde2f54	2016-02-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089097 application number: ANDA089097

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
905199	hydrALAZINE HCl 10 MG Oral Tablet	PSN	66c5eaa4-a51a-464b-98ad-f094f32876dd	2
905225	hydrALAZINE HCl 25 MG Oral Tablet	PSN	66c5eaa4-a51a-464b-98ad-f094f32876dd	2
905395	hydrALAZINE HCl 50 MG Oral Tablet	PSN	66c5eaa4-a51a-464b-98ad-f094f32876dd	2
905199	hydralazine hydrochloride 10 MG Oral Tablet	SCD	66c5eaa4-a51a-464b-98ad-f094f32876dd	2
905225	hydralazine hydrochloride 25 MG Oral Tablet	SCD	66c5eaa4-a51a-464b-98ad-f094f32876dd	2
905395	hydralazine hydrochloride 50 MG Oral Tablet	SCD	66c5eaa4-a51a-464b-98ad-f094f32876dd	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
48433-046-01	48433004601	1 in 1 BLISTER PACK					Historical
48433-046-20	48433004620	100 BLISTER PACK in 1 CARTON (48433-046-20) / 1 TABLET in 1 BLISTER PACK (48433-046-01)	100 blister pack	2026-03-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HydrALAZINE Hydrochloride Tablets USP	Safecor Health, LLC	2026-03-11	HUMAN PRESCRIPTION DRUG LABEL	2