FDA.reportPublic FDA data

HYDRALAZINE HYDROCHLORIDE

Product NDC
63629-5696
11-digit product format
636295696
Labeler code
63629
Product ID
63629-5696_1b917255-4f41-4984-bb71-5cdff4938e3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydralazine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA086242
Marketing category
ANDA
Marketing start
2007-04-06
Marketing end
2026-08-31
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HYDRALAZINE HYDROCHLORIDE

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-5696-12024-05-16C16284748780-19d75b9d0-c7ae-f424-e053-dadaa90a57ceRx only
63629-5696-22024-05-16C16284748780-19d75b9d0-c7ae-f424-e053-dadaa90a57ceRx only
63629-5696-32024-05-16C16284748780-19d75b9d0-c7ae-f424-e053-dadaa90a57ceRx only
63629-5696-42024-05-16C16284748780-19d75b9d0-c7ae-f424-e053-dadaa90a57ceRx only
63629-5696-12024-01-30C16284748780-19d75b9d0-c7ae-f424-e053-dadaa90a57ceRx only
63629-5696-22024-01-30C16284748780-19d75b9d0-c7ae-f424-e053-dadaa90a57ceRx only
63629-5696-32024-01-30C16284748780-19d75b9d0-c7ae-f424-e053-dadaa90a57ceRx only
63629-5696-42024-01-30C16284748780-19d75b9d0-c7ae-f424-e053-dadaa90a57ceRx only
63629-5696-12020-10-16C16284748780-19d75b9d0-c7ae-f424-e053-dadaa90a57ceRx only
63629-5696-22020-10-16C16284748780-19d75b9d0-c7ae-f424-e053-dadaa90a57ceRx only
63629-5696-32020-10-16C16284748780-19d75b9d0-c7ae-f424-e053-dadaa90a57ceRx only
63629-5696-12020-01-31C16284748780-19d75b9d0-c7ae-f424-e053-dadaa90a57ceRx only
63629-5696-22020-01-31C16284748780-19d75b9d0-c7ae-f424-e053-dadaa90a57ceRx only
63629-5696-32020-01-31C16284748780-19d75b9d0-c7ae-f424-e053-dadaa90a57ceRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-5696-1HYDRALAZINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED307
63629-5696-2HYDRALAZINE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED607
63629-5696-3HYDRALAZINE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED907
63629-5696-4HYDRALAZINE HYDROCHLORIDE10 in 1 BOTTLETABLET, FILM COATED107
63629-5696-5HYDRALAZINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5696HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 5 package rows20240517_db138daf-2d2d-4730-a621-a1bd209d5b9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905225hydrALAZINE HCl 25 MG Oral TabletPSNdb138daf-2d2d-4730-a621-a1bd209d5b9f7
905225hydralazine hydrochloride 25 MG Oral TabletSCDdb138daf-2d2d-4730-a621-a1bd209d5b9f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-5696-16362956960130 TABLET, FILM COATED in 1 BOTTLE (63629-5696-1) 2017-06-292026-08-31NoNoCurrent
63629-5696-26362956960260 TABLET, FILM COATED in 1 BOTTLE (63629-5696-2) 2016-06-242026-08-31NoNoCurrent
63629-5696-36362956960390 TABLET, FILM COATED in 1 BOTTLE (63629-5696-3) 2015-07-152026-08-31NoNoCurrent
63629-5696-46362956960410 TABLET, FILM COATED in 1 BOTTLE (63629-5696-4) 2024-04-022026-08-31NoNoCurrent
63629-5696-563629569605100 TABLET, FILM COATED in 1 BOTTLE (63629-5696-5) 2026-04-032026-08-31NoNoHistorical