FDA.reportPublic FDA data

HydrALAZINE Hydrochloride

Product NDC
71335-1236
11-digit product format
713351236
Labeler code
71335
Product ID
71335-1236_47ad263b-ad3d-4f98-b0aa-d9e82ab6cb67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HydrALAZINE Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200770
Marketing category
ANDA
Marketing start
2013-06-30
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
2023-12-31
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
71335-1236-12024-01-30C16284748780-11030e365-0187-111a-e063-dadaa90a10e2HydrALAZINE HYDROCHLORIDE TABLETS, USP
71335-1236-22024-01-30C16284748780-11030e365-0187-111a-e063-dadaa90a10e2HydrALAZINE HYDROCHLORIDE TABLETS, USP
71335-1236-32024-01-30C16284748780-11030e365-0187-111a-e063-dadaa90a10e2HydrALAZINE HYDROCHLORIDE TABLETS, USP
71335-1236-42024-01-30C16284748780-11030e365-0187-111a-e063-dadaa90a10e2HydrALAZINE HYDROCHLORIDE TABLETS, USP
71335-1236-52024-01-30C16284748780-11030e365-0187-111a-e063-dadaa90a10e2HydrALAZINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1236-1HydrALAZINE Hydrochloride30 in 1 BOTTLETABLET302
71335-1236-2HydrALAZINE Hydrochloride60 in 1 BOTTLETABLET602
71335-1236-3HydrALAZINE Hydrochloride120 in 1 BOTTLETABLET1202
71335-1236-4HydrALAZINE Hydrochloride90 in 1 BOTTLETABLET902
71335-1236-5HydrALAZINE Hydrochloride10 in 1 BOTTLETABLET102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1236HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2Legacy NDC, 5 package rows20220204_47ad263b-ad3d-4f98-b0aa-d9e82ab6cb67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905395hydrALAZINE HCl 50 MG Oral TabletPSN47ad263b-ad3d-4f98-b0aa-d9e82ab6cb672
905395hydralazine hydrochloride 50 MG Oral TabletSCD47ad263b-ad3d-4f98-b0aa-d9e82ab6cb672

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1236-17133512360130 TABLET in 1 BOTTLE (71335-1236-1) 30 tablet2015-02-020000-00-00NoNoCurrent
71335-1236-27133512360260 TABLET in 1 BOTTLE (71335-1236-2) 60 tablet2015-02-020000-00-00NoNoCurrent
71335-1236-371335123603120 TABLET in 1 BOTTLE (71335-1236-3) 120 tablet2015-02-020000-00-00NoNoCurrent
71335-1236-47133512360490 TABLET in 1 BOTTLE (71335-1236-4) 90 tablet2015-02-020000-00-00NoNoCurrent
71335-1236-57133512360510 TABLET in 1 BOTTLE (71335-1236-5) 10 tablet2021-12-280000-00-00NoNoCurrent