Hydralazine Hydrochloride

Product NDC
50090-0139
11-digit product format
500900139
Labeler code
50090
Product ID
50090-0139_d14a312f-cf30-4282-8387-ac085046255b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040901
Marketing category
ANDA
Marketing start
2010-01-01
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
50090-0139-0Hydralazine Hydrochloride100 in 1 BOTTLETABLET10031
50090-0139-1Hydralazine Hydrochloride60 in 1 BOTTLETABLET6031
50090-0139-2Hydralazine Hydrochloride180 in 1 BOTTLETABLET18031
50090-0139-3Hydralazine Hydrochloride90 in 1 BOTTLETABLET9031
50090-0139-4Hydralazine Hydrochloride270 in 1 BOTTLETABLET27031

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0139HYDRALAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]27Current NDC, Legacy NDC, 5 package rows20230623_f16f1d87-f9e6-4555-9baf-26ff17cb1d28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905225hydrALAZINE HCl 25 MG Oral TabletPSNf16f1d87-f9e6-4555-9baf-26ff17cb1d2831
905395hydrALAZINE HCl 50 MG Oral TabletPSNf16f1d87-f9e6-4555-9baf-26ff17cb1d2831
905225hydralazine hydrochloride 25 MG Oral TabletSCDf16f1d87-f9e6-4555-9baf-26ff17cb1d2831
905395hydralazine hydrochloride 50 MG Oral TabletSCDf16f1d87-f9e6-4555-9baf-26ff17cb1d2831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0139-050090013900100 TABLET in 1 BOTTLE (50090-0139-0) 100 tablet2018-12-110000-00-00NoNoCurrent
50090-0139-15009001390160 TABLET in 1 BOTTLE (50090-0139-1) 60 tablet2014-11-280000-00-00NoNoCurrent
50090-0139-250090013902180 TABLET in 1 BOTTLE (50090-0139-2) 180 tablet2014-11-280000-00-00NoNoCurrent
50090-0139-35009001390390 TABLET in 1 BOTTLE (50090-0139-3) 90 tablet2018-12-110000-00-00NoNoCurrent
50090-0139-450090013904270 TABLET in 1 BOTTLE (50090-0139-4) 270 tablet2020-01-210000-00-00NoNoCurrent