HYDRALAZINE HYDROCHLORIDE

Product NDC: 71209-018
11-digit product format: 712090018
Labeler code: 71209
Product ID: 71209-018_4cdbf75c-b17f-4c40-bd7c-7b07668e9659
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydralazine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Cadila Pharmaceuticals Limited
Application: ANDA203845
Marketing category: ANDA
Marketing start: 2015-12-29
Substance: HYDRALAZINE HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203845-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18
A203845-002	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18
A203845-003	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203845-001	AA
A203845-002	AA
A203845-003	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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203845-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203845-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203845-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203845-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203845-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203845-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203845-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203845-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203845-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203845-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203845-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203845-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203845-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203845-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203845-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203845-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203845-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203845-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203845-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203845-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203845-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203845-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203845-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203845-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203845-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203845-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203845-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203845-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203845-003	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203845-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203845-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203845-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203845-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203845-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203845-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203845-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203845-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203845-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203845-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203845-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203845-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203845-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203845-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203845-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203845-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203845-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203845-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203845-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203845-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203845-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203845-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203845-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203845-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203845-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203845-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203845-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203845-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203845-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203845-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203845-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203845-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203845-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203845-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203845-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203845-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203845-001	AA	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: HYDRALAZINE HYDROCHLORIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDRALAZINE HYDROCHLORIDE	100 mg/1

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
905222	Internal RxNorm lookup
905225	Internal RxNorm lookup
905395	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
3a7562a8-2f67-4411-ac4a-ab7924193e82	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
0284f4a6-db58-dacf-18fe-da73f4aeea88	Product name	4	20180827
0ad8bdca-888e-00da-648b-6a4de854a167	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71209-018-05	HYDRALAZINE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET	100		6
71209-018-11	HYDRALAZINE HYDROCHLORIDE	1000 in 1 BOTTLE	TABLET	1000		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71209-018	HYDRALAZINE HYDROCHLORIDE TABLET [CADILA PHARMACEUTICALS LIMITED]	6	Current NDC, Legacy NDC, 2 package rows	20221230_3a7562a8-2f67-4411-ac4a-ab7924193e82.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Coupler LLC	2df51a19-a39a-0ec8-e063-6394a90a147c	2025-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203845 application number: ANDA203845
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Modavar Pharmaceuticals LLC	a456bc34-0c79-44f4-9119-50028a978f5f	2024-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203845 application number: ANDA203845
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Cadila Pharmaceuticals Limited	3a7562a8-2f67-4411-ac4a-ab7924193e82	2022-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203845 application number: ANDA203845 ndc (product): 71209-018
Hydralazine	HYDRALAZINE HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	1fd8cf42-66ae-4af5-a5ae-7c9679a0e532	2022-02-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203845 application number: ANDA203845

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
905222	hydrALAZINE HCl 100 MG Oral Tablet	PSN	3a7562a8-2f67-4411-ac4a-ab7924193e82	6
905225	hydrALAZINE HCl 25 MG Oral Tablet	PSN	3a7562a8-2f67-4411-ac4a-ab7924193e82	6
905395	hydrALAZINE HCl 50 MG Oral Tablet	PSN	3a7562a8-2f67-4411-ac4a-ab7924193e82	6
905222	hydralazine hydrochloride 100 MG Oral Tablet	SCD	3a7562a8-2f67-4411-ac4a-ab7924193e82	6
905225	hydralazine hydrochloride 25 MG Oral Tablet	SCD	3a7562a8-2f67-4411-ac4a-ab7924193e82	6
905395	hydralazine hydrochloride 50 MG Oral Tablet	SCD	3a7562a8-2f67-4411-ac4a-ab7924193e82	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71209-018-05	71209001805	100 TABLET in 1 BOTTLE (71209-018-05)	100 tablet	2015-12-29	0000-00-00	No	No	Current
71209-018-11	71209001811	1000 TABLET in 1 BOTTLE (71209-018-11)	1000 tablet	2015-12-29	0000-00-00	No	No	Current