FDA.reportPublic FDA data

Hydralazine Hydrochloride

Product NDC
50090-3834
11-digit product format
500903834
Labeler code
50090
Product ID
50090-3834_ef8eb89e-cfb8-4fef-bdf0-c780f49409ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydralazine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA086242
Marketing category
ANDA
Marketing start
2007-04-06
Marketing end
0000-00-00
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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
50090-3834-12023-01-30C16284748780-1f386c64a-4650-0266-e053-dadaa90a7c1aRx only
50090-3834-22023-01-30C16284748780-1f386c64a-4650-0266-e053-dadaa90a7c1aRx only
50090-3834-32023-01-30C16284748780-1f386c64a-4650-0266-e053-dadaa90a7c1aRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3834-1Hydralazine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED605
50090-3834-2Hydralazine Hydrochloride180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1805
50090-3834-3Hydralazine Hydrochloride1 in 1 BOTTLE, PLASTICTABLET, FILM COATED15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3834HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Legacy NDC, 3 package rows20210417_9fc2bf1a-1017-4465-a333-3f974763585a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905395hydrALAZINE HCl 50 MG Oral TabletPSN9fc2bf1a-1017-4465-a333-3f974763585a5
905395hydralazine hydrochloride 50 MG Oral TabletSCD9fc2bf1a-1017-4465-a333-3f974763585a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3834-15009038340160 TABLET, FILM COATED in 1 BOTTLE (50090-3834-1) 2018-11-140000-00-00NoNoCurrent
50090-3834-250090383402180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3834-2) 2014-11-280000-00-00NoNoCurrent
50090-3834-3500903834031 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3834-3) 2014-11-280000-00-00NoNoCurrent