Hydralazine Hydrochloride

Product NDC
43353-919
11-digit product format
433530919
Labeler code
43353
Product ID
43353-919_959e4ed8-d633-4f2c-a52d-775c3ef577df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA086242
Marketing category
ANDA
Marketing start
2007-04-06
Marketing end
0000-00-00
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
43353-919-162020-01-31C16284748780-19d75b9d0-9fac-f424-e053-dadaa90a57ceHYDRALAZINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-919-16Hydralazine Hydrochloride6000 in 1 BOTTLE, PLASTICTABLET, FILM COATED60001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-919HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 1 package rows20140708_66d82f90-5f6d-41ef-b7ac-750403333e7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905222hydrALAZINE HCl 100 MG Oral TabletPSN66d82f90-5f6d-41ef-b7ac-750403333e7d1
905225hydrALAZINE HCl 25 MG Oral TabletPSN66d82f90-5f6d-41ef-b7ac-750403333e7d1
905395hydrALAZINE HCl 50 MG Oral TabletPSN66d82f90-5f6d-41ef-b7ac-750403333e7d1
905222hydralazine hydrochloride 100 MG Oral TabletSCD66d82f90-5f6d-41ef-b7ac-750403333e7d1
905225hydralazine hydrochloride 25 MG Oral TabletSCD66d82f90-5f6d-41ef-b7ac-750403333e7d1
905395hydralazine hydrochloride 50 MG Oral TabletSCD66d82f90-5f6d-41ef-b7ac-750403333e7d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-919-16433530919166000 in 1 BOTTLE, PLASTICHistorical