Hydralazine Hydrochloride

Product NDC
55154-9554
11-digit product format
551549554
Labeler code
55154
Product ID
55154-9554_858b3d0d-fbaf-47dc-ab92-3afe2877fdd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDRALAZINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Cardinal Health 107, LLC
Application
ANDA040388
Marketing category
ANDA
Marketing start
2001-09-05
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
20 mg/mL
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 HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFD171B778Y
Rxcui966571

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
55154-9554-5Hydralazine Hydrochloride5 in 1 BAGINJECTION59
55154-9554-5Hydralazine Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-9554HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH 107, LLC]9Current NDC, Legacy NDC, 2 package rows20250522_43ce0ecb-6d62-44bf-8539-823ae03eb9f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966571hydrALAZINE HCl 20 MG in 1 ML InjectionPSN43ce0ecb-6d62-44bf-8539-823ae03eb9f49
9665711 ML hydralazine hydrochloride 20 MG/ML InjectionSCD43ce0ecb-6d62-44bf-8539-823ae03eb9f49
966571hydralazine HCl 20 MG per 1 ML InjectionSY43ce0ecb-6d62-44bf-8539-823ae03eb9f49

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-9554-5551549554055 VIAL, SINGLE-DOSE in 1 BAG (55154-9554-5) / 1 mL in 1 VIAL, SINGLE-DOSE2001-09-050000-00-00NoNoCurrent