HYDRALAZINE HYDROCHLORIDE

Product NDC: 63629-5696
11-digit product format: 636295696
Labeler code: 63629
Product ID: 63629-5696_db138daf-2d2d-4730-a621-a1bd209d5b9f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydralazine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA086242
Marketing category: ANDA
Marketing start: 2007-04-06
Marketing end: 0000-00-00
Substance: HYDRALAZINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-5696		D	Discontinued by firm	2026-10-16
excluded package	package	63629-5696	63629-5696-1	D	Discontinued by firm	2026-10-16
excluded package	package	63629-5696	63629-5696-2	D	Discontinued by firm	2026-10-16
excluded package	package	63629-5696	63629-5696-3	D	Discontinued by firm	2026-10-16
excluded package	package	63629-5696	63629-5696-4	D	Discontinued by firm	2026-10-16
excluded package	package	63629-5696	63629-5696-5	D	Discontinued by firm	2026-10-16

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 · 14 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
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63629-5696-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63629-5696-2	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63629-5696-4	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63629-5696-3	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63629-5696-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63629-5696-2	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63629-5696-4	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63629-5696-3	`1332a3947898…`	`d4bfe170f9cd…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-5696-1	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-5696-3	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-5696-2	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
A086242-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2010-02-04
A086242-002	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982
A086242-003	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982
A086242-004	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL		2010-02-04

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 5 · 176 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
2026-10-15 13:18:30	2026-09	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL			2010-02-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL			2010-02-04	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL			2010-02-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL			2010-02-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL			2010-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL			2010-02-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086242-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2010-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086242-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086242-003	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086242-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA		2010-02-04	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 160 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086242-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086242-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086242-003	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086242-004	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086242-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086242-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086242-003	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086242-004	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086242-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086242-002	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086242-003	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086242-004	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086242-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A086242-002	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A086242-003	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A086242-004	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086242-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086242-002	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086242-003	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086242-004	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086242-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A086242-002	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A086242-003	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A086242-004	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086242-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A086242-002	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A086242-003	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A086242-004	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086242-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A086242-002	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A086242-003	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A086242-004	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086242-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A086242-002	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A086242-003	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A086242-004	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086242-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A086242-002	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A086242-003	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A086242-004	AA	1	`782e0a99824c…`

Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-5696-1	2024-05-16	Rx only
63629-5696-2	2024-05-16	Rx only
63629-5696-3	2024-05-16	Rx only
63629-5696-4	2024-05-16	Rx only
63629-5696-1	2024-01-30	Rx only
63629-5696-2	2024-01-30	Rx only
63629-5696-3	2024-01-30	Rx only
63629-5696-4	2024-01-30	Rx only
63629-5696-1	2020-10-16	Rx only
63629-5696-2	2020-10-16	Rx only
63629-5696-3	2020-10-16	Rx only
63629-5696-1	2020-01-31	Rx only
63629-5696-2	2020-01-31	Rx only
63629-5696-3	2020-01-31	Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63629-5696-1	HYDRALAZINE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, FILM COATED	30	7
63629-5696-2	HYDRALAZINE HYDROCHLORIDE	60 in 1 BOTTLE	TABLET, FILM COATED	60	7
63629-5696-3	HYDRALAZINE HYDROCHLORIDE	90 in 1 BOTTLE	TABLET, FILM COATED	90	7
63629-5696-4	HYDRALAZINE HYDROCHLORIDE	10 in 1 BOTTLE	TABLET, FILM COATED	10	7
63629-5696-5	HYDRALAZINE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, FILM COATED	100	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-5696	HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	6	Legacy NDC, 5 package rows	20240517_db138daf-2d2d-4730-a621-a1bd209d5b9f.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	PD-Rx Pharmaceuticals, Inc.	e9450e82-329f-4fd8-a0b3-3e8e22715965	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086242 application number: ANDA086242
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Chartwell RX, LLC	0c7f9bd0-6c0a-4521-b77a-3582faa96874	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086242 application number: ANDA086242
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Proficient Rx LP	63f388e0-9f3d-4902-990c-9a105aa098ad	2020-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086242 application number: ANDA086242

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
905225	hydrALAZINE HCl 25 MG Oral Tablet	PSN	db138daf-2d2d-4730-a621-a1bd209d5b9f	7
905225	hydralazine hydrochloride 25 MG Oral Tablet	SCD	db138daf-2d2d-4730-a621-a1bd209d5b9f	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-5696-1	63629569601	30 TABLET, FILM COATED in 1 BOTTLE (63629-5696-1)	2017-02-07	0000-00-00	No	No	Current
63629-5696-2	63629569602	60 TABLET, FILM COATED in 1 BOTTLE (63629-5696-2)	2016-06-28	0000-00-00	No	No	Current
63629-5696-3	63629569603	90 TABLET, FILM COATED in 1 BOTTLE (63629-5696-3)	2015-07-17	0000-00-00	No	No	Current
63629-5696-4	63629569604	10 TABLET, FILM COATED in 1 BOTTLE (63629-5696-4)	2022-02-08	0000-00-00	No	No	Current
63629-5696-5	63629569605	100 in 1 BOTTLE					Historical