FDA.reportPublic FDA data

NDC 51079-076-01 - 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
51079-076
Requested NDC
51079-076-01
Package NDCs from labels
51079-076-01, 51079-076-20
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
HydrALAZINE Hydrochloride Tablets USPMylan Institutional Inc. | Teva Pharmaceuticals USA, Inc.2025-07-22HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51079-076-01Hydralazine Hydrochloride1 in 1 BLISTER PACKTABLET115
51079-076-20Hydralazine Hydrochloride100 in 1 CARTONTABLET10015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-076HYDRALAZINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]14Current NDC, Legacy NDC, 2 package rows20230404_493a8b7e-5bb1-4db2-91a7-77ed87864131.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-076-01EA - Each51079-0768b76f720-9777-4128-a0d8-6896c1eae83112012-07-24
51079-076-20EA - Each51079-076c92ca3bb-2d53-47cb-9b92-e8c3351524a512012-07-24

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
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933HYDRALAZINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDRALAZINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDRALAZINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDRALAZINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDRALAZINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDRALAZINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]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 6 · 103 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.51c293c1-70e7-48c7-8af1-a8b74312ed562026-09-08Warnings, Adverse reactionsExact identifier
rxcui: 905222
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.6c40d818-77a9-492c-b9b6-d8a0fe8d67362026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 905225
unii: FD171B778Y
hydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.dca82025-a4cd-4856-aa19-bdf091bf89732026-08-14Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEBryant Ranch Prepackd2d98842-ff32-4a61-94e0-60e06919948f2026-08-14Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905222
unii: FD171B778Y
HydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDECoupler LLC58773e8c-b6bc-6bc6-e063-6294a90adc262026-08-07Warnings, Adverse reactionsExact identifier
rxcui: 905395
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECardinal Health 107, LLCdb7500f3-f8a6-46b1-bb64-9727617a96432026-07-30Warnings, Adverse reactionsExact identifier
application number: ANDA088467
application number: ANDA088468
ndc (package): 55154-5689-0
ndc (package): 55154-5085-0
ndc (product): 55154-5085
ndc (product): 55154-5689
rxcui: 905225
rxcui: 905395
spl id: 0489db42-3dc0-4415-a2a6-ea6833c93590
spl set id: db7500f3-f8a6-46b1-bb64-9727617a9643
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEMajor Pharmaceuticalsb6ccd35e-f69c-4eef-a456-905e030ae9112026-07-15Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905199
rxcui: 905395
rxcui: 905222
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDENorthwind Health Company, LLC1275dd50-d97f-2e8f-e063-6394a90a4a672026-06-22Warnings, Adverse reactionsExact identifier
rxcui: 905225
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECardinal Health 107, LLC8b7e88ef-5edd-40df-8e43-e3f29970be582026-06-19Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.d61ffa06-8138-4a1d-9530-095a80d9c9ce2026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 905395
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.a70d20d6-23f0-477e-915c-678a867821752026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 905199
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.0d65e146-83e5-427f-ac06-04c0d8e72cea2026-06-09Warnings, Adverse reactionsExact identifier
rxcui: 905225
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECardinal Health 107, LLC43ce0ecb-6d62-44bf-8539-823ae03eb9f42026-06-03Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDECardinal Health 107, LLCa1066707-2391-4918-8ded-600c017fde482026-05-18Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905395
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc.438479d0-ff61-4008-a0fc-1ee44b97cf7f2026-05-07Warnings, Adverse reactionsExact identifier
rxcui: 905222
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.f0db9c3c-d841-46f9-8409-9ffca83d7a972026-05-06Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDENavinta LLCae5d85df-11a3-4952-ade2-596d57cdd9872026-04-21Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.669532c9-ba15-4f4b-95a8-13782deb35212026-04-03Warnings, Adverse reactionsExact identifier
rxcui: 905225
rxcui: 905199
rxcui: 905395
rxcui: 905222
unii: FD171B778Y
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDESafecor Health, LLC66c5eaa4-a51a-464b-98ad-f094f32876dd2026-03-11Warnings, Adverse reactionsExact identifier
application number: ANDA089097
application number: ANDA088467
application number: ANDA088468
rxcui: 905225
rxcui: 905199
rxcui: 905395
unii: FD171B778Y
HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEMeitheal Pharmaceuticals Inc.f3c806a4-b971-421c-bcb9-9979c6d7aaec2026-02-27Warnings, Adverse reactionsExact identifier
unii: FD171B778Y

Reported adverse events (FAERS/openFDA)#

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