Hydralazine Hydrochloride

Product NDC: 17478-834
11-digit product format: 174780834
Labeler code: 17478
Product ID: 17478-834_547ca932-b451-44de-b6c2-ad98b1b7c96b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydralazine Hydrochloride
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Akorn, Inc.
Application: ANDA040730
Marketing category: ANDA
Marketing start: 2013-02-21
Marketing end: 0000-00-00
Substance: HYDRALAZINE HYDROCHLORIDE
Active strength: 20 mg/mL
Pharmacologic classes: Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	17478-834		D	Discontinued by firm	2026-08-11
excluded package	package	17478-834	17478-834-01	D	Discontinued by firm	2026-08-11
excluded package	package	17478-834	17478-834-15	D	Discontinued by firm	2026-08-11

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 · 36 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17478-834-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17478-834-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17478-834-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17478-834-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17478-834-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17478-834-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17478-834-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17478-834-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17478-834-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17478-834-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17478-834-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17478-834-15	`cdf11ea48f46…`	`ba0047e9e063…`
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	17478-834-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17478-834-15	`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	17478-834-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17478-834-15	`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	17478-834-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17478-834-15	`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	17478-834-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17478-834-15	`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	17478-834-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17478-834-15	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17478-834-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17478-834-15	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A040730-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2009-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040730-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2009-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2009-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2009-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2009-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2009-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2009-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2009-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2009-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2009-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2009-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040730-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2009-04-21	`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	A040730-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040730-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040730-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040730-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040730-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040730-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040730-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040730-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040730-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040730-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040730-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040730-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040730-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040730-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040730-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040730-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040730-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040730-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040730-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040730-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040730-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040730-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040730-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040730-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040730-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040730-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040730-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040730-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040730-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040730-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040730-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040730-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040730-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040730-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040730-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040730-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040730-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040730-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040730-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040730-001	AP	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-834-01	ML - Milliliter	17478-834	75afe00f-8102-477a-9073-b85990c5e0a8	1	2013-08-02
17478-834-15	ML - Milliliter	17478-834	c3a00b5e-d99b-45ff-a9e9-37d01a479d88	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Hydralazine Hydrochloride	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE INJECTION [AKORN, INC.]	1
Hydralazine	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE INJECTION [AKORN, INC.]	1
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	HYDRALAZINE HYDROCHLORIDE INJECTION [AKORN, INC.]	1
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	HYDRALAZINE HYDROCHLORIDE INJECTION [AKORN, INC.]	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	HYDRALAZINE HYDROCHLORIDE INJECTION [AKORN, INC.]	1
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDRALAZINE HYDROCHLORIDE INJECTION [AKORN, INC.]	1
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	HYDRALAZINE HYDROCHLORIDE INJECTION [AKORN, INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	HYDRALAZINE HYDROCHLORIDE INJECTION [AKORN, INC.]	1

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	94530e4d-b1c0-6171-e053-2a95a90a05fa	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040730 application number: ANDA040730

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FD171B778Y	HYDRALAZINE HYDROCHLORIDE	304-20-1	HYDRALAZINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
17478-834-01	17478083401	10 VIAL, SINGLE-DOSE in 1 CARTON (17478-834-01) > 1 mL in 1 VIAL, SINGLE-DOSE	2013-02-21	0000-00-00	No	No	Current
17478-834-15	17478083415	25 VIAL, SINGLE-DOSE in 1 CARTON (17478-834-15) > 1 mL in 1 VIAL, SINGLE-DOSE	2013-02-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HydrALAZINE Hydrochloride Injection, USP	Akorn, Inc. \| Akorn Operating Company LLC \| Akorn, Inc	2020-10-08	HUMAN PRESCRIPTION DRUG LABEL	3