Application 088468

Type: ANDA
Sponsor: PLIVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	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
A088468-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A088468-001	AA

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	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	1984-05-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	1984-05-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	1984-05-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	1984-05-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	1984-05-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	1984-05-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	1984-05-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RS	1984-05-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088468-001	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	RLD, RS	1984-05-01	`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	A088468-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088468-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088468-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088468-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088468-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088468-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088468-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088468-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088468-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088468-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088468-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088468-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088468-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088468-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088468-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088468-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088468-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088468-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088468-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088468-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088468-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088468-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088468-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088468-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088468-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088468-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088468-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088468-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088468-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088468-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088468-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088468-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088468-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088468-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088468-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088468-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088468-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088468-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088468-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088468-001	AA	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Safecor Health, LLC	66c5eaa4-a51a-464b-98ad-f094f32876dd	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088468 application number: ANDA088468
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Cardinal Health 107, LLC	db7500f3-f8a6-46b1-bb64-9727617a9643	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088468 application number: ANDA088468 ndc (product): 55154-5085
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Mylan Institutional Inc.	493a8b7e-5bb1-4db2-91a7-77ed87864131	2025-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088468 application number: ANDA088468 ndc (product): 51079-076
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	A-S Medication Solutions	e617023e-b060-4db9-a97e-e2b11a37901e	2023-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088468 application number: ANDA088468
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	ddbbdb09-3202-42d7-bbb0-08331dde2f54	2016-02-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088468 application number: ANDA088468 ndc (product): 50111-328

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-2514	Hydralazine Hydrochloride	Hydralazine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2514	Hydralazine Hydrochloride	Hydralazine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2514	Hydralazine Hydrochloride	Hydralazine Hydrochloride	A-S Medication Solutions	ANDA	Current
50111-328	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-328	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-328	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-328	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
51079-076	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-076	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-076	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-076	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Mylan Institutional Inc.	ANDA	Current
55154-1487	Hydralazine	Hydralazine	Cardinal Health	ANDA	Current
55154-1487	Hydralazine	Hydralazine	Cardinal Health	ANDA	Current
55154-1490	Hydralazine	Hydralazine	Cardinal Health	ANDA	Current
55154-1490	Hydralazine	Hydralazine	Cardinal Health	ANDA	Current
55154-5085	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Cardinal Health	ANDA	Current
55154-5085	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Cardinal Health	ANDA	Current
55154-5085	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Cardinal Health	ANDA	Current
63739-127	Hydralazine Hydrochloride	Hydralazine Hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-127	Hydralazine Hydrochloride	Hydralazine Hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-127	Hydralazine Hydrochloride	Hydralazine Hydrochloride	McKesson Corporation	ANDA	Current
65084-127	Hydralazine Hydrochloride	Hydralazine Hydrochloride	McKesson Corporation dba RX Pak	ANDA	Current
65084-127	Hydralazine Hydrochloride	Hydralazine Hydrochloride	McKesson Corporation dba RX Pak	ANDA	Current
70518-1868	Hydralazine Hydrochloride	Hydralazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current