FDA.reportPublic FDA data

NDC 62584-733-11 - 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
62584-733
Requested NDC
62584-733-11
Package NDCs from labels
62584-733-11, 62584-733-01
Manufacturer
American Health Packaging
Effective date
2024-04-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydralazine Hydrochloride - American Health PackagingAmerican Health Packaging2024-04-04HUMAN PRESCRIPTION DRUG LABEL
Hydralazine Hydrochloride - Cardinal Health 107, LLCCardinal Health 107, LLC2022-12-20HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62584-733HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]10Legacy NDC20240405_26ba8da4-9752-46d3-a1ab-c5eee2bbd5ee.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62584-733-01EA - Each62584-7339f363633-a864-4db5-a89d-04c27a8bb92012012-07-24
62584-733-11EA - Each62584-73379c076f1-44b4-437e-93b3-c9e492ad676e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]6
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]6
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPHYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]6
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPHYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDRALAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]3

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 115 · 2,295 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.51c293c1-70e7-48c7-8af1-a8b74312ed562026-09-08Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
OilMINERAL OILAtlantic Biologicals Corp.5a82197b-281d-76c0-e063-6294a90a57462026-09-02Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILYour Military Exchanges6025dce6-02e8-418c-a248-0b5c33ff60672026-08-28Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Hydralazine HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.6c40d818-77a9-492c-b9b6-d8a0fe8d67362026-08-27Warnings, Adverse reactionsExact identifier
unii: FD171B778Y
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Mineral Oil/White PetrolatumMINERAL OIL/WHITE PETROLATUMYYBA CORP5967ef02-6770-bfd7-e063-6294a90a79042026-08-19WarningsExact identifier
unii: T5L8T28FGP
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
hydrALAZINE HydrochlorideHYDRALAZINE HYDROCHLORIDEREMEDYREPACK INC.dca82025-a4cd-4856-aa19-bdf091bf89732026-08-14Warnings, Adverse reactionsExact identifier
unii: FD171B778Y

Reported adverse events (FAERS/openFDA)#

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