Hydralazine Hydrochloride

Product NDC
55154-9554
11-digit product format
551549554
Labeler code
55154
Product ID
55154-9554_858b3d0d-fbaf-47dc-ab92-3afe2877fdd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDRALAZINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Cardinal Health 107, LLC
Application
ANDA040388
Marketing category
ANDA
Marketing start
2001-09-05
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040388-001HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2001-03-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040388-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2001-03-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2001-03-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2001-03-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2001-03-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2001-03-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2001-03-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2001-03-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2001-03-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2001-03-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAPRS2001-03-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-133f01610625f2…
2019-09-15 20:21 UTC2019-09A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040388-001HYDRALAZINE HYDROCHLORIDE20MG/MLINJECTABLE / INJECTIONAP2001-03-13cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040388-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040388-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040388-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040388-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040388-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040388-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040388-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040388-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040388-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040388-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040388-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040388-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040388-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040388-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040388-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040388-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040388-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040388-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040388-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040388-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040388-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A040388-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040388-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040388-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040388-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A040388-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040388-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040388-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040388-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040388-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040388-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040388-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040388-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040388-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040388-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040388-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040388-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040388-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040388-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040388-001AP1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Hydralazine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDRALAZINE HYDROCHLORIDE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FD171B778YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
966571Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
43ce0ecb-6d62-44bf-8539-823ae03eb9f4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3137695-e199-b3b3-2950-87a8ac429689Product name520260316
e9ed2ee5-d109-4795-bffe-c3b047717749Product name220250107
0284f4a6-db58-dacf-18fe-da73f4aeea88Product name420180827
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-9554-5Hydralazine Hydrochloride5 in 1 BAGINJECTION59
55154-9554-5Hydralazine Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]4
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBHYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-9554HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH 107, LLC]9Current NDC, Legacy NDC, 2 package rows20250522_43ce0ecb-6d62-44bf-8539-823ae03eb9f4.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECardinal Health 107, LLC8b7e88ef-5edd-40df-8e43-e3f29970be582026-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040388
application number: ANDA040388
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECardinal Health 107, LLC43ce0ecb-6d62-44bf-8539-823ae03eb9f42026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040388
application number: ANDA040388
ndc (product): 55154-9554
hydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.dca82025-a4cd-4856-aa19-bdf091bf89732026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040388
application number: ANDA040388
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEFresenius Kabi USA, LLCbf1b7c2f-535c-45bb-928a-65606d87685e2025-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040388
application number: ANDA040388
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEFresenius Kabi USA, LLCf34904dc-c945-4de4-8594-34e4f4ac19832025-11-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040388
application number: ANDA040388
hydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEProPharma Distribution3855c3da-ff25-8301-e063-6294a90a22b32025-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040388
application number: ANDA040388
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEHenry Schein, Inc.4d1f55aa-e924-4540-ae9f-bd7362a82f332025-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040388
application number: ANDA040388
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst9949407f-e410-7f47-e053-2995a90a73692024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040388
application number: ANDA040388
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEMedical Purchasing Solutions, LLC7979c865-737d-d999-e053-2a91aa0abc5e2023-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040388
application number: ANDA040388
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEMedical Purchasing Solutions, LLCdd2cd8a1-7bdd-05e4-e053-2995a90ad3662023-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040388
application number: ANDA040388
hydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEFresenius Kabi USA, LLCc3797028-c625-4f70-ae69-8a5f6f23f1b82022-08-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040388
application number: ANDA040388
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEFresenius Kabi USA, LLC8223c44a-73a9-4da5-a468-d1d8bdb0bbd62022-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040388
application number: ANDA040388

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966571hydrALAZINE HCl 20 MG in 1 ML InjectionPSN43ce0ecb-6d62-44bf-8539-823ae03eb9f49
9665711 ML hydralazine hydrochloride 20 MG/ML InjectionSCD43ce0ecb-6d62-44bf-8539-823ae03eb9f49
966571hydralazine HCl 20 MG per 1 ML InjectionSY43ce0ecb-6d62-44bf-8539-823ae03eb9f49

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-9554-5551549554055 VIAL, SINGLE-DOSE in 1 BAG (55154-9554-5) / 1 mL in 1 VIAL, SINGLE-DOSE2001-09-050000-00-00NoNoCurrent