hydrALAZINE Hydrochloride

Product NDC: 70518-3659
11-digit product format: 705183659
Labeler code: 70518
Product ID: 70518-3659_5905ae5e-7ec3-d680-e063-6294a90aa154
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydrALAZINE Hydrochloride
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: REMEDYREPACK INC.
Application: ANDA040388
Marketing category: ANDA
Marketing start: 2023-02-27
Substance: HYDRALAZINE HYDROCHLORIDE
Active strength: 20 mg/mL
Pharmacologic classes: Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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	70518-3659	70518-3659-0	D	Discontinued by firm		2026-10-05

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 · 11 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…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A040388-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2001-03-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040388-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2001-03-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2001-03-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2001-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2001-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2001-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2001-03-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2001-03-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2001-03-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2001-03-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2001-03-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2001-03-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	RS	2001-03-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040388-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040388-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040388-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040388-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040388-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040388-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040388-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040388-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040388-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040388-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040388-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040388-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040388-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040388-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040388-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040388-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040388-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040388-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040388-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040388-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040388-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040388-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040388-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040388-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040388-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040388-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040388-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040388-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040388-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040388-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040388-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040388-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040388-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040388-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040388-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040388-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040388-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040388-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040388-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040388-001	AP	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	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
dca82025-a4cd-4856-aa19-bdf091bf8973	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	SPL version
70518-3659-0	hydrALAZINE Hydrochloride	25 in 1 TRAY	INJECTION	25	3
70518-3659-0	hydrALAZINE Hydrochloride	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION	1	3
70518-3659-1	hydrALAZINE Hydrochloride	25 in 1 TRAY	INJECTION	25	3
70518-3659-2	hydrALAZINE Hydrochloride	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3659	HYDRALAZINE HYDROCHLORIDE INJECTION [REMEDYREPACK INC.]	1	Current NDC, 4 package rows	20240922_dca82025-a4cd-4856-aa19-bdf091bf8973.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
hydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	dca82025-a4cd-4856-aa19-bdf091bf8973	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040388 application number: ANDA040388 ndc (product): 70518-3659
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Cardinal Health 107, LLC	8b7e88ef-5edd-40df-8e43-e3f29970be58	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040388 application number: ANDA040388
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Cardinal Health 107, LLC	43ce0ecb-6d62-44bf-8539-823ae03eb9f4	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040388 application number: ANDA040388
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	bf1b7c2f-535c-45bb-928a-65606d87685e	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040388 application number: ANDA040388
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	f34904dc-c945-4de4-8594-34e4f4ac1983	2025-11-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040388 application number: ANDA040388
hydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	ProPharma Distribution	3855c3da-ff25-8301-e063-6294a90a22b3	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040388 application number: ANDA040388
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Henry Schein, Inc.	4d1f55aa-e924-4540-ae9f-bd7362a82f33	2025-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040388 application number: ANDA040388
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	9949407f-e410-7f47-e053-2995a90a7369	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040388 application number: ANDA040388
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	7979c865-737d-d999-e053-2a91aa0abc5e	2023-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040388 application number: ANDA040388
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	dd2cd8a1-7bdd-05e4-e053-2995a90ad366	2023-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040388 application number: ANDA040388
hydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	c3797028-c625-4f70-ae69-8a5f6f23f1b8	2022-08-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040388 application number: ANDA040388
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	8223c44a-73a9-4da5-a468-d1d8bdb0bbd6	2022-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040388 application number: ANDA040388

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	dca82025-a4cd-4856-aa19-bdf091bf8973	3
966571	1 ML hydralazine hydrochloride 20 MG/ML Injection	SCD	dca82025-a4cd-4856-aa19-bdf091bf8973	3
966571	hydralazine HCl 20 MG per 1 ML Injection	SY	dca82025-a4cd-4856-aa19-bdf091bf8973	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-3659-0	70518365900	25 in 1 TRAY					Historical
70518-3659-1	70518365901	25 VIAL, SINGLE-DOSE in 1 TRAY (70518-3659-1) / 1 mL in 1 VIAL, SINGLE-DOSE (70518-3659-2)		2024-09-19	No	No	Current
70518-3659-2	70518365902	1 mL in 1 VIAL, SINGLE-DOSE	1 ml				Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
hydrALAZINE Hydrochloride Injection, USP	REMEDYREPACK INC.	2026-08-14	HUMAN PRESCRIPTION DRUG LABEL	4