hydrALAZINE Hydrochloride

Product NDC: 63323-614
11-digit product format: 633230614
Labeler code: 63323
Product ID: 63323-614_2f8362b3-0a39-40b0-95bf-4a786cb15a74
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydrALAZINE Hydrochloride
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA040388
Marketing category: ANDA
Marketing start: 2011-01-31
Substance: HYDRALAZINE HYDROCHLORIDE
Active strength: 20 mg/mL
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 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…`

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	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
c3797028-c625-4f70-ae69-8a5f6f23f1b8	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	SPL version
63323-614-16	Hydralazine Hydrochloride	25 in 1 TRAY	INJECTION	25	12
63323-614-41	Hydralazine Hydrochloride	1 mL in 1 VIAL, SINGLE-USE	INJECTION	1	12
63323-614-00	Hydralazine Hydrochloride	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION	1	6
63323-614-01	Hydralazine Hydrochloride	25 in 1 CARTON	INJECTION	25	6
63323-614-21	hydrALAZINE Hydrochloride	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION	1	5
63323-614-55	hydrALAZINE Hydrochloride	25 in 1 TRAY	INJECTION	25	5
63323-614-03	Hydralazine Hydrochloride	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION	1	1
63323-614-06	Hydralazine Hydrochloride	25 in 1 CARTON	INJECTION	25	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-614-00	ML - Milliliter	63323-614	e805ab0a-5d3c-47ca-b6a9-f259bd0be77e	1	2018-07-03
63323-614-01	ML - Milliliter	63323-614	24c76541-8711-454d-8045-1541be109d81	1	2012-07-24
63323-614-03	ML - Milliliter	63323-614	620b9d9f-07d6-4935-a12f-a4751e30a7de	1	2026-02-05
63323-614-06	ML - Milliliter	63323-614	368da241-e5a9-4520-9f87-ff9fb0bb381b	1	2026-02-05
63323-614-16	ML - Milliliter	63323-614	032b94ea-0e8e-41ca-b85d-63c0d5229fd2	1	2015-10-02
63323-614-21	ML - Milliliter	63323-614	b91eda93-e4f2-4235-a120-aa7e57e83529	1	2024-03-12
63323-614-41	ML - Milliliter	63323-614	a31640cb-3fc6-40af-9b1c-c1b4850df428	1	2024-04-05
63323-614-55	ML - Milliliter	63323-614	4731af4b-bba4-440b-8a07-b942a4bcabe4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDRALAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	10
HYDRALAZINE	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	10
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	10
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	10
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	10
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	10
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	10
HYDRALAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	4
HYDRALAZINE	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	4
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	4
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	4
HYDRALAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	3
HYDRALAZINE	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	3
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	3
HYDRALAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	2
HYDRALAZINE HYDROCHLORIDE	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	2
Hydralazine Hydrochloride	ACTIVE INGREDIENT	FD171B778Y	HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	2
HYDRALAZINE	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	2
HYDRALAZINE	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	2
Hydralazine	ACTIVE MOIETY	26NAK24LS8	HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-614	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	12	Current NDC, Legacy NDC, 2 package rows	20220604_8223c44a-73a9-4da5-a468-d1d8bdb0bbd6.zip
63323-614	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	5	Current NDC, Legacy NDC, 2 package rows	20220419_f34904dc-c945-4de4-8594-34e4f4ac1983.zip
63323-614	HYDRALAZINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC]	5	Current NDC, Legacy NDC, 2 package rows	20220820_c3797028-c625-4f70-ae69-8a5f6f23f1b8.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 · 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
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
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
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
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

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	8223c44a-73a9-4da5-a468-d1d8bdb0bbd6	12
966571	1 ML hydralazine hydrochloride 20 MG/ML Injection	SCD	8223c44a-73a9-4da5-a468-d1d8bdb0bbd6	12
966571	hydralazine HCl 20 MG per 1 ML Injection	SY	8223c44a-73a9-4da5-a468-d1d8bdb0bbd6	12
966571	hydrALAZINE HCl 20 MG in 1 ML Injection	PSN	43ce0ecb-6d62-44bf-8539-823ae03eb9f4	9
966571	1 ML hydralazine hydrochloride 20 MG/ML Injection	SCD	43ce0ecb-6d62-44bf-8539-823ae03eb9f4	9
966571	hydralazine HCl 20 MG per 1 ML Injection	SY	43ce0ecb-6d62-44bf-8539-823ae03eb9f4	9
966571	hydrALAZINE HCl 20 MG in 1 ML Injection	PSN	9949407f-e410-7f47-e053-2995a90a7369	6
966571	hydrALAZINE HCl 20 MG in 1 ML Injection	PSN	f34904dc-c945-4de4-8594-34e4f4ac1983	6
966571	1 ML hydralazine hydrochloride 20 MG/ML Injection	SCD	f34904dc-c945-4de4-8594-34e4f4ac1983	6
966571	1 ML hydralazine hydrochloride 20 MG/ML Injection	SCD	9949407f-e410-7f47-e053-2995a90a7369	6
966571	hydralazine HCl 20 MG per 1 ML Injection	SY	f34904dc-c945-4de4-8594-34e4f4ac1983	6
966571	hydralazine HCl 20 MG per 1 ML Injection	SY	9949407f-e410-7f47-e053-2995a90a7369	6
966571	hydrALAZINE HCl 20 MG in 1 ML Injection	PSN	c3797028-c625-4f70-ae69-8a5f6f23f1b8	5
966571	1 ML hydralazine hydrochloride 20 MG/ML Injection	SCD	c3797028-c625-4f70-ae69-8a5f6f23f1b8	5
966571	hydralazine HCl 20 MG per 1 ML Injection	SY	c3797028-c625-4f70-ae69-8a5f6f23f1b8	5
966571	hydrALAZINE HCl 20 MG in 1 ML Injection	PSN	c5647a72-22da-420a-a549-7b5185a621d4	4
966571	1 ML hydralazine hydrochloride 20 MG/ML Injection	SCD	c5647a72-22da-420a-a549-7b5185a621d4	4
966571	hydralazine HCl 20 MG per 1 ML Injection	SY	c5647a72-22da-420a-a549-7b5185a621d4	4
966571	hydrALAZINE HCl 20 MG in 1 ML Injection	PSN	7979c865-737d-d999-e053-2a91aa0abc5e	3
966571	hydrALAZINE HCl 20 MG in 1 ML Injection	PSN	dca82025-a4cd-4856-aa19-bdf091bf8973	3
966571	1 ML hydralazine hydrochloride 20 MG/ML Injection	SCD	7979c865-737d-d999-e053-2a91aa0abc5e	3
966571	1 ML hydralazine hydrochloride 20 MG/ML Injection	SCD	dca82025-a4cd-4856-aa19-bdf091bf8973	3
966571	hydralazine HCl 20 MG per 1 ML Injection	SY	7979c865-737d-d999-e053-2a91aa0abc5e	3
966571	hydralazine HCl 20 MG per 1 ML Injection	SY	dca82025-a4cd-4856-aa19-bdf091bf8973	3
966571	hydrALAZINE HCl 20 MG in 1 ML Injection	PSN	3855c3da-ff25-8301-e063-6294a90a22b3	2
966571	hydrALAZINE HCl 20 MG in 1 ML Injection	PSN	8b7e88ef-5edd-40df-8e43-e3f29970be58	2
966571	hydrALAZINE HCl 20 MG in 1 ML Injection	PSN	dd2cd8a1-7bdd-05e4-e053-2995a90ad366	2
966571	hydrALAZINE HCl 20 MG in 1 ML Injection	PSN	4d1f55aa-e924-4540-ae9f-bd7362a82f33	2
966571	1 ML hydralazine hydrochloride 20 MG/ML Injection	SCD	8b7e88ef-5edd-40df-8e43-e3f29970be58	2
966571	1 ML hydralazine hydrochloride 20 MG/ML Injection	SCD	3855c3da-ff25-8301-e063-6294a90a22b3	2
966571	1 ML hydralazine hydrochloride 20 MG/ML Injection	SCD	4d1f55aa-e924-4540-ae9f-bd7362a82f33	2
966571	1 ML hydralazine hydrochloride 20 MG/ML Injection	SCD	dd2cd8a1-7bdd-05e4-e053-2995a90ad366	2
966571	hydralazine HCl 20 MG per 1 ML Injection	SY	dd2cd8a1-7bdd-05e4-e053-2995a90ad366	2
966571	hydralazine HCl 20 MG per 1 ML Injection	SY	3855c3da-ff25-8301-e063-6294a90a22b3	2
966571	hydralazine HCl 20 MG per 1 ML Injection	SY	8b7e88ef-5edd-40df-8e43-e3f29970be58	2
966571	hydralazine HCl 20 MG per 1 ML Injection	SY	4d1f55aa-e924-4540-ae9f-bd7362a82f33	2
966571	hydrALAZINE HCl 20 MG in 1 ML Injection	PSN	bf1b7c2f-535c-45bb-928a-65606d87685e	1
966571	1 ML hydralazine hydrochloride 20 MG/ML Injection	SCD	bf1b7c2f-535c-45bb-928a-65606d87685e	1
966571	hydralazine HCl 20 MG per 1 ML Injection	SY	bf1b7c2f-535c-45bb-928a-65606d87685e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-614-00	63323061400	1 mL in 1 VIAL, SINGLE-DOSE	1 ml					Historical
63323-614-01	63323061401	25 VIAL, SINGLE-DOSE in 1 CARTON (63323-614-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-614-00)		2001-09-05	0000-00-00	No	No	Current
63323-614-03	63323061403	1 mL in 1 VIAL, SINGLE-DOSE	1 ml					Historical
63323-614-06	63323061406	25 VIAL, SINGLE-DOSE in 1 CARTON (63323-614-06) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-614-03)		2001-09-05		No	No	Current
63323-614-16	63323061416	25 VIAL, SINGLE-USE in 1 TRAY (63323-614-16) / 1 mL in 1 VIAL, SINGLE-USE (63323-614-41)		2001-09-05	0000-00-00	No	No	Current
63323-614-21	63323061421	1 mL in 1 VIAL, SINGLE-DOSE	1 ml					Historical
63323-614-41	63323061441	1 mL in 1 VIAL, SINGLE-USE	1 ml					Historical
63323-614-55	63323061455	25 VIAL, SINGLE-DOSE in 1 TRAY (63323-614-55) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-614-21)		2011-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydralazine Hydrochloride Injection, USP	Cardinal Health 107, LLC	2026-06-19	HUMAN PRESCRIPTION DRUG LABEL	3
Hydralazine Hydrochloride Injection, USP	Cardinal Health 107, LLC	2026-06-03	HUMAN PRESCRIPTION DRUG LABEL	10
hydrALAZINE Hydrochloride Injection, USP	REMEDYREPACK INC.	2026-04-14	HUMAN PRESCRIPTION DRUG LABEL	3
Hydralazine Hydrochloride Injection, USP	Fresenius Kabi USA, LLC	2025-12-16	HUMAN PRESCRIPTION DRUG LABEL	1
Hydralazine Hydrochloride Injection, USP	Fresenius Kabi USA, LLC	2025-11-28	HUMAN PRESCRIPTION DRUG LABEL	6
hydrALAZINE Hydrochloride Injection, USP	ProPharma Distribution	2025-07-18	HUMAN PRESCRIPTION DRUG LABEL	2
Hydralazine Hydrochloride Injection, USP	Henry Schein, Inc.	2025-05-20	HUMAN PRESCRIPTION DRUG LABEL	2
HYDRALAZINE HYDROCHLORIDE INJECTION, USP 20mg per mL	HF Acquisition Co LLC, DBA HealthFirst	2024-01-30	HUMAN PRESCRIPTION DRUG LABEL	6
Hydralazine Hydrochloride Injection, USP	Medical Purchasing Solutions, LLC	2023-05-16	HUMAN PRESCRIPTION DRUG LABEL	3
Hydralazine Hydrochloride Injection, USP	Medical Purchasing Solutions, LLC	2023-05-02	HUMAN PRESCRIPTION DRUG LABEL	2
hydrALAZINE Hydrochloride Injection, USP	Fresenius Kabi USA, LLC	2022-08-09	HUMAN PRESCRIPTION DRUG LABEL	5
Hydralazine Hydrochloride Injection, USP	Fresenius Kabi USA, LLC	2022-05-18	HUMAN PRESCRIPTION DRUG LABEL	12
Hydralazine Hydrochloride Injection, USP	A-S Medication Solutions	2021-04-15	Human Prescription Drug Label	4
hydrALAZINE Hydrochloride Injection, USP	Cardinal Health	2020-07-10	HUMAN PRESCRIPTION DRUG LABEL	5
Hydralazine HCL 20mg/mL 1mL single dose vial	General Injectables & Vaccines, Inc	2019-12-12	HUMAN PRESCRIPTION DRUG LABEL	6