Hydralazine Hydrochloride

Product NDC
63629-5246
11-digit product format
636295246
Labeler code
63629
Product ID
63629-5246_608758ea-f449-4ae7-895e-0c8c2b88cc38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
Rxcui905395

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
63629-5246-1Hydralazine Hydrochloride30 in 1 BOTTLETABLET301008
63629-5246-2Hydralazine Hydrochloride60 in 1 BOTTLETABLET601008
63629-5246-3Hydralazine Hydrochloride120 in 1 BOTTLETABLET1201008
63629-5246-4Hydralazine Hydrochloride90 in 1 BOTTLETABLET901008

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5246HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1008Current NDC, Legacy NDC, 4 package rows20250327_90c18c55-3045-4a10-a2bb-012e4a5e1564.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905395hydrALAZINE HCl 50 MG Oral TabletPSN90c18c55-3045-4a10-a2bb-012e4a5e15641008
905395hydralazine hydrochloride 50 MG Oral TabletSCD90c18c55-3045-4a10-a2bb-012e4a5e15641008

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-5246-16362952460130 TABLET in 1 BOTTLE (63629-5246-1) 30 tablet2014-03-040000-00-00NoNoCurrent
63629-5246-26362952460260 TABLET in 1 BOTTLE (63629-5246-2) 60 tablet2014-03-040000-00-00NoNoCurrent
63629-5246-363629524603120 TABLET in 1 BOTTLE (63629-5246-3) 120 tablet2014-03-040000-00-00NoNoCurrent
63629-5246-46362952460490 TABLET in 1 BOTTLE (63629-5246-4) 90 tablet2014-03-040000-00-00NoNoCurrent