HydrALAZINE Hydrochloride

Product NDC: 43353-205
11-digit product format: 433530205
Labeler code: 43353
Product ID: 43353-205_7ff2351c-0271-49c1-b5d4-cb73b76a508c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HydrALAZINE Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA090255
Marketing category: ANDA
Marketing start: 2016-05-20
Substance: HYDRALAZINE HYDROCHLORIDE
Active strength: 100 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	Approval date
A090255-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-12-15
A090255-002	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-15
A090255-003	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-15
A090255-004	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2008-12-15

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090255-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090255-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090255-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090255-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2008-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090255-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090255-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090255-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090255-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2008-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090255-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090255-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090255-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090255-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2008-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090255-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090255-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090255-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090255-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2008-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090255-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090255-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090255-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090255-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2008-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090255-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090255-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090255-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090255-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2008-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090255-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090255-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090255-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090255-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2008-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090255-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090255-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090255-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090255-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2008-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090255-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090255-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090255-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090255-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2008-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090255-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090255-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090255-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090255-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2008-12-15	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 104 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090255-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090255-002	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090255-003	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090255-004	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090255-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090255-002	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090255-003	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090255-004	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090255-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090255-002	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090255-003	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090255-004	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090255-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090255-002	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090255-003	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090255-004	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090255-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090255-002	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090255-003	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090255-004	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090255-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090255-002	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090255-003	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090255-004	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090255-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090255-002	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090255-003	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090255-004	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090255-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090255-002	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090255-003	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090255-004	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090255-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090255-002	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090255-003	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090255-004	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090255-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090255-002	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090255-003	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090255-004	AA	1	`c0c555d07b60…`

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	100 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
905222	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
921c8693-84c2-4313-a2a6-ab3be637d554	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
43353-205-05	HydrALAZINE Hydrochloride	4200 in 1 BOTTLE	TABLET	4200		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-205-05	EA - Each	43353-205	e97fba90-0370-4b03-a337-0c5465b7d35d	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-205	HYDRALAZINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Current NDC, Legacy NDC, 1 package rows	20160714_921c8693-84c2-4313-a2a6-ab3be637d554.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Exelan Pharmaceuticals Inc.	811831f9-a844-463a-874d-fb8407659f0b	2020-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090255 application number: ANDA090255
HydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	921c8693-84c2-4313-a2a6-ab3be637d554	2016-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090255 application number: ANDA090255 ndc (product): 43353-205

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
905222	hydrALAZINE HCl 100 MG Oral Tablet	PSN	921c8693-84c2-4313-a2a6-ab3be637d554	1
905222	hydralazine hydrochloride 100 MG Oral Tablet	SCD	921c8693-84c2-4313-a2a6-ab3be637d554	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-205-05	43353020505	4200 TABLET in 1 BOTTLE (43353-205-05)	4200 tablet	2016-07-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HydrALAZINE HYDROCHLORIDE TABLETS, USP	Aphena Pharma Solutions - Tennessee, LLC	2016-07-14	HUMAN PRESCRIPTION DRUG LABEL	1