Hydralazine Hydrochloride

Product NDC
55154-5085
11-digit product format
551545085
Labeler code
55154
Product ID
55154-5085_a165dff2-f60a-4183-afe3-3adc336763a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA088468
Marketing category
ANDA
Marketing start
2011-05-13
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydralazine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDRALAZINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFD171B778Y
Rxcui905225, 905395

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
55154-5085-0Hydralazine 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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905225hydrALAZINE HCl 25 MG Oral TabletPSNdb7500f3-f8a6-46b1-bb64-9727617a964318
905395hydrALAZINE HCl 50 MG Oral TabletPSNdb7500f3-f8a6-46b1-bb64-9727617a964318
905225hydralazine hydrochloride 25 MG Oral TabletSCDdb7500f3-f8a6-46b1-bb64-9727617a964318
905395hydralazine hydrochloride 50 MG Oral TabletSCDdb7500f3-f8a6-46b1-bb64-9727617a964318

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-5085-05515450850010 BLISTER PACK in 1 BAG (55154-5085-0) / 1 TABLET in 1 BLISTER PACK10 blister pack2011-05-130000-00-00NoNoCurrent