Application 040388

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	INJECTABLE;INJECTION	20MG/ML	No	No

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
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 · 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	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…`
2022-09-29 23:25 UTC	2022-09	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040388-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2001-03-13	`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	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…`
2022-09-29 23:25 UTC	2022-09	A040388-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040388-001	AP	1	`cb3db0bc1861…`

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	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 ndc (product): 55154-9554
hydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	dca82025-a4cd-4856-aa19-bdf091bf8973	2026-04-14	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 ndc (product): 63323-614
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 ndc (product): 63323-614
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 ndc (product): 51662-1376
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 ndc (product): 71872-7145
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 ndc (product): 71872-7268
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 ndc (product): 63323-614
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 ndc (product): 63323-614

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4518	Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
50090-4518	Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
51662-1376	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1376	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1376	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1376	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
52584-614	Hydralazine Hydrochloride	Hydralazine Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-614	Hydralazine Hydrochloride	Hydralazine Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
55154-9367	Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Cardinal Health	ANDA	Current
55154-9367	Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Cardinal Health	ANDA	Current
55154-9554	Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Cardinal Health	ANDA	Current
63323-614	Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-614	hydrALAZINE Hydrochloride	hydrALAZINE Hydrochloride	Fresenius Kabi USA, LLC	ANDA	Current
63323-614	Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-614	Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-614	Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-614	Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-614	Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-614	hydrALAZINE Hydrochloride	hydrALAZINE Hydrochloride	Fresenius Kabi USA, LLC	ANDA	Current
71872-7145	Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7145	Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7268	Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
7643	ORIG	2001-03-13