Hydralazine Hydrochloride

Product NDC
55154-6628
11-digit product format
551546628
Labeler code
55154
Product ID
55154-6628_9b83bc08-9a57-4b18-bb9a-cda537a276e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health
Application
ANDA086242
Marketing category
ANDA
Marketing start
2010-09-10
Marketing end
0000-00-00
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-6628HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]12Legacy NDC20240508_993a4f55-421b-4c41-af0f-7f6237b8e429.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-6628-05515466280010 BLISTER PACK in 1 BAG (55154-6628-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2010-09-100000-00-00NoNoCurrent