Hydralazine Hydrochloride

Product NDC: 0517-0901
11-digit product format: 005170901
Labeler code: 0517
Product ID: 0517-0901_5aca9ccd-3ac3-48b6-9372-34ee0eb4b7f9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydralazine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: American Regent, Inc.
Application: ANDA040136
Marketing category: ANDA
Marketing start: 1997-06-30
Substance: HYDRALAZINE HYDROCHLORIDE
Active strength: 20 mg/mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040136-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		1997-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040136-001	AP

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		1997-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		1997-06-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		1997-06-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		1997-06-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		1997-06-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040136-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040136-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040136-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040136-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040136-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040136-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040136-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040136-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040136-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040136-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040136-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040136-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040136-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040136-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040136-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040136-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040136-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A040136-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040136-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040136-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040136-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040136-001	AP	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040136-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040136-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040136-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040136-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040136-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040136-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040136-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040136-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040136-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040136-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040136-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040136-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040136-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040136-001	AP	1	`a50c72e98297…`

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	20 mg/mL

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
966571	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
17210abc-58f6-442e-8ff2-7971333c82f6	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
0517-0901-25	Hydralazine Hydrochloride	25 in 1 TRAY	INJECTION, SOLUTION	25		8
0517-0901-25	Hydralazine Hydrochloride	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	1		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0517-0901-25	ML - Milliliter	0517-0901	7ab8e644-ac86-4809-9209-72a48b8cb5d6	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDRALAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	5
HYDRALAZINE	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	5
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	5
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	5
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	5
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0517-0901	HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]	8	Current NDC, Legacy NDC, 2 package rows	20190507_17210abc-58f6-442e-8ff2-7971333c82f6.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Civica, Inc.	ffa483a4-de2a-4d42-ad27-afacd37f28e4	2024-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040136 application number: ANDA040136
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	15b0f03b-b5a2-c49d-e063-6394a90a5b15	2024-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040136 application number: ANDA040136
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	American Regent, Inc.	17210abc-58f6-442e-8ff2-7971333c82f6	2019-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040136 application number: ANDA040136 ndc (product): 0517-0901

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
966571	hydrALAZINE HCl 20 MG in 1 ML Injection	PSN	17210abc-58f6-442e-8ff2-7971333c82f6	8
966571	1 ML hydralazine hydrochloride 20 MG/ML Injection	SCD	17210abc-58f6-442e-8ff2-7971333c82f6	8
966571	hydralazine HCl 20 MG per 1 ML Injection	SY	17210abc-58f6-442e-8ff2-7971333c82f6	8
966571	hydrALAZINE HCl 20 MG in 1 ML Injection	PSN	15b0f03b-b5a2-c49d-e063-6394a90a5b15	2
966571	1 ML hydralazine hydrochloride 20 MG/ML Injection	SCD	15b0f03b-b5a2-c49d-e063-6394a90a5b15	2
966571	hydralazine HCl 20 MG per 1 ML Injection	SY	15b0f03b-b5a2-c49d-e063-6394a90a5b15	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0517-0901-25	00517090125	25 VIAL, SINGLE-DOSE in 1 TRAY (0517-0901-25) / 1 mL in 1 VIAL, SINGLE-DOSE	1997-06-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDRALAZINE HYDROCHLORIDE - HF Acquisition Co LLC, DBA HealthFirst	HF Acquisition Co LLC, DBA HealthFirst	2024-04-09	HUMAN PRESCRIPTION DRUG LABEL	2
HydrALAZINE Hydrochloride Injection, USP	American Regent, Inc.	2019-05-06	HUMAN PRESCRIPTION DRUG LABEL	8