Hydralazine Hydrochloride

Product NDC
50090-0137
11-digit product format
500900137
Labeler code
50090
Product ID
50090-0137_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
25 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 HYDROCHLORIDE25 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
50090-0137-0Hydralazine Hydrochloride100 in 1 BOTTLETABLET10031
50090-0137-2Hydralazine Hydrochloride60 in 1 BOTTLETABLET6031
50090-0137-4Hydralazine Hydrochloride180 in 1 BOTTLETABLET18031
50090-0137-5Hydralazine Hydrochloride90 in 1 BOTTLETABLET9031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0137-2EA - Each50090-013717d094af-1989-448b-a08e-cc5ff1ee453012023-02-06
50090-0137-4EA - Each50090-0137326f7435-e304-4847-be43-555b81bcc75712021-05-05
50090-0137-5EA - Each50090-0137742f9b25-b1a1-41a8-80e4-cb9036dbd24412023-02-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDRALAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDRALAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDRALAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDRALAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDRALAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0137HYDRALAZINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]27Current NDC, Legacy NDC, 4 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
50090-0137-050090013700100 TABLET in 1 BOTTLE (50090-0137-0) 100 tablet2020-10-120000-00-00NoNoCurrent
50090-0137-25009001370260 TABLET in 1 BOTTLE (50090-0137-2) 60 tablet2020-10-120000-00-00NoNoCurrent
50090-0137-450090013704180 TABLET in 1 BOTTLE (50090-0137-4) 180 tablet2014-11-280000-00-00NoNoCurrent
50090-0137-55009001370590 TABLET in 1 BOTTLE (50090-0137-5) 90 tablet2021-06-060000-00-00NoNoCurrent