Hydralazine Hydrochloride

Product NDC: 68475-514
11-digit product format: 684750514
Labeler code: 68475
Product ID: 68475-514_e9ca27ef-fa6d-4b88-a84b-9a56bffe2020
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydralazine Hydrochloride
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Navinta LLC
Application: ANDA202938
Marketing category: ANDA
Marketing start: 2025-11-25
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

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
A202938-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		2013-03-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202938-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202938-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2013-03-28	`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	A202938-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202938-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202938-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202938-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202938-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202938-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202938-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202938-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202938-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202938-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202938-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202938-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202938-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202938-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202938-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202938-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202938-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202938-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202938-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202938-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202938-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202938-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202938-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202938-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202938-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202938-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202938-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202938-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202938-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202938-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202938-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202938-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202938-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202938-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202938-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202938-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202938-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202938-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202938-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202938-001	AP	1	`cb3db0bc1861…`

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
ae5d85df-11a3-4952-ade2-596d57cdd987	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	Strength	SPL version
68475-514-01	Hydralazine Hydrochloride	1 mL in 1 VIAL	INJECTION	1		2
68475-514-02	Hydralazine Hydrochloride	25 in 1 PACKAGE	INJECTION	25		2

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	f0db9c3c-d841-46f9-8409-9ffca83d7a97	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202938 application number: ANDA202938
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Navinta LLC	ae5d85df-11a3-4952-ade2-596d57cdd987	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202938 application number: ANDA202938 ndc (product): 68475-514

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	ae5d85df-11a3-4952-ade2-596d57cdd987	2
966571	1 ML hydralazine hydrochloride 20 MG/ML Injection	SCD	ae5d85df-11a3-4952-ade2-596d57cdd987	2
966571	hydralazine HCl 20 MG per 1 ML Injection	SY	ae5d85df-11a3-4952-ade2-596d57cdd987	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68475-514-01	68475051401	1 mL in 1 VIAL	1 ml				Historical
68475-514-02	68475051402	25 VIAL in 1 PACKAGE (68475-514-02) / 1 mL in 1 VIAL (68475-514-01)	25 vial	2025-11-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydralazine Hydrochloride Injection, USP Preservative Free Rx only	Navinta LLC	2026-04-21	HUMAN PRESCRIPTION DRUG LABEL	2