Hydralazine Hydrochloride

Product NDC
0615-7973
11-digit product format
006157973
Labeler code
0615
Product ID
0615-7973_502998b4-a486-4c38-ae3a-a47512d2c58c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA040901
Marketing category
ANDA
Marketing start
2010-01-01
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFD171B778Y
Rxcui905222

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
0615-7973-05Hydralazine Hydrochloride15 in 1 BLISTER PACKTABLET156
0615-7973-39Hydralazine Hydrochloride30 in 1 BLISTER PACKTABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-7973HYDRALAZINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]6Current NDC, Legacy NDC, 2 package rows20240814_f07abdec-6d94-45b6-be1b-10a898ea28c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905222hydrALAZINE HCl 100 MG Oral TabletPSNf07abdec-6d94-45b6-be1b-10a898ea28c26
905222hydralazine hydrochloride 100 MG Oral TabletSCDf07abdec-6d94-45b6-be1b-10a898ea28c26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-7973-050061579730515 TABLET in 1 BLISTER PACK (0615-7973-05) 15 tablet2022-11-100000-00-00NoNoCurrent
0615-7973-390061579733930 TABLET in 1 BLISTER PACK (0615-7973-39) 30 tablet2010-01-010000-00-00NoNoCurrent