FDA.reportPublic FDA data

NDC 55154-5085-00 - Hydralazine Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
55154-5085
Requested NDC
55154-5085-00
Package NDCs from labels
55154-5085-0, 55154-5085-00
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-07-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydralazine Hydrochloride - Cardinal Health 107, LLCCardinal Health 107, LLC2026-07-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-5085-0Hydralazine Hydrochloride1 in 1 BLISTER PACKTABLET118
55154-5085-0Hydralazine Hydrochloride10 in 1 BAGTABLET1018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-5085HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH 107, LLC]17Current NDC, Legacy NDC, 2 package rows20240723_db7500f3-f8a6-46b1-bb64-9727617a9643.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]7
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]7
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]7

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 2 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECoupler LLC4aa1b3e8-9389-fe2c-e063-6294a90a7fb92026-02-12Warnings, Adverse reactionsExact identifier
rxcui: 905225
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.89afc8ef-27c4-489a-81de-3f8f65f6bbb82026-02-09Warnings, Adverse reactionsExact identifier
rxcui: 905225
unii: FD171B778Y
HydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEStrides Pharma Science Limitedb3d1786d-c3ff-42f1-a09f-37a9c9021e5a2026-02-02Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905199
rxcui: 905395
unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.e9450e82-329f-4fd8-a0b3-3e8e227159652026-01-07Warnings, Adverse reactionsExact identifier
rxcui: 905395
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEFresenius Kabi USA, LLCbf1b7c2f-535c-45bb-928a-65606d87685e2025-12-16Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEChartwell RX, LLC0c7f9bd0-6c0a-4521-b77a-3582faa968742025-12-10Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905199
rxcui: 905395
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEA-S Medication Solutions7253aaa0-e272-499f-9bfa-304e9556a8fb2025-12-05Warnings, Adverse reactionsExact identifier
rxcui: 905395
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEA-S Medication Solutionsf16f1d87-f9e6-4555-9baf-26ff17cb1d282025-12-05Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905395
unii: FD171B778Y
BiDilHYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATEAzurity Pharmaceuticals, Inc.e1e63cd5-d1e4-4af5-bad5-1ad41ea46b002025-11-30Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEFresenius Kabi USA, LLCf34904dc-c945-4de4-8594-34e4f4ac19832025-11-28Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEEugia US LLCe08d8b6c-a184-4dd5-84ef-bac90e4b1c332025-11-11Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECardinal Health 107, LLC336b11da-e592-4386-921f-3c136d754f2a2025-11-06Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905395
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECoupler LLC41c019e3-7b07-5f12-e063-6294a90a53652025-10-22Warnings, Adverse reactionsExact identifier
rxcui: 905199
unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEMedical Purchasing Solutions, LLC3f8fb1fc-ffef-4f94-e063-6294a90a2b822025-09-24Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEMylan Institutional Inc.493a8b7e-5bb1-4db2-91a7-77ed878641312025-07-22Warnings, Adverse reactionsExact identifier
application number: ANDA088467
application number: ANDA088468
ndc (product): 51079-076
ndc (product): 51079-075
rxcui: 905225
rxcui: 905199
rxcui: 905395
spl id: 3a8625af-ede6-2b68-e063-6394a90a4536
spl set id: 493a8b7e-5bb1-4db2-91a7-77ed87864131
unii: FD171B778Y
hydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEProPharma Distribution3855c3da-ff25-8301-e063-6294a90a22b32025-07-18Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEProficient Rx LP024ac6b8-5ce0-4435-9b11-b1806c511d7b2025-07-01Warnings, Adverse reactionsExact identifier
rxcui: 905225
unii: FD171B778Y
Isosorbide dinitrate and hydralazine hydrochlorideISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDEIngenus Pharmaceuticals, LLC8f54d5a3-169f-48dd-9250-2c176d2bd9ad2025-06-03Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEHenry Schein, Inc.4d1f55aa-e924-4540-ae9f-bd7362a82f332025-05-20Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepacka79ddc89-546b-4808-879d-c0f5921416362025-03-31Warnings, Adverse reactionsExact identifier
rxcui: 905199
unii: FD171B778Y

Reported adverse events (FAERS/openFDA)#

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