Hydralazine Hydrochloride

Product NDC
63629-8757
11-digit product format
636298757
Labeler code
63629
Product ID
63629-8757_3335c836-5e3d-4b72-b9d1-b3365cbe28b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA088467
Marketing category
ANDA
Marketing start
1990-09-30
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

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
63629-8757-1Hydralazine Hydrochloride1000 in 1 BOTTLETABLET1000103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8757-1EA - Each63629-87572ff48f21-9035-4857-b5ba-d76c447799cf12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8757HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20241109_10f3e76e-9bba-4151-89fb-90d823a0a68c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905225hydrALAZINE HCl 25 MG Oral TabletPSN10f3e76e-9bba-4151-89fb-90d823a0a68c103
905225hydralazine hydrochloride 25 MG Oral TabletSCD10f3e76e-9bba-4151-89fb-90d823a0a68c103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8757-1636298757011000 TABLET in 1 BOTTLE (63629-8757-1) 1000 tablet2021-08-200000-00-00NoNoCurrent