FDA.reportPublic FDA data

Hydralazine Hydrochloride

Product NDC
43353-742
11-digit product format
433530742
Labeler code
43353
Product ID
43353-742_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
50 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
43353-742-602020-01-31C16284748780-19d75b9d0-9fac-f424-e053-dadaa90a57ceHYDRALAZINE HYDROCHLORIDE TABLETS, USP
43353-742-802020-01-31C16284748780-19d75b9d0-9fac-f424-e053-dadaa90a57ceHYDRALAZINE HYDROCHLORIDE TABLETS, USP
43353-742-922020-01-31C16284748780-19d75b9d0-9fac-f424-e053-dadaa90a57ceHYDRALAZINE HYDROCHLORIDE TABLETS, USP
43353-742-942020-01-31C16284748780-19d75b9d0-9fac-f424-e053-dadaa90a57ceHYDRALAZINE HYDROCHLORIDE TABLETS, USP
43353-742-962020-01-31C16284748780-19d75b9d0-9fac-f424-e053-dadaa90a57ceHYDRALAZINE HYDROCHLORIDE TABLETS, USP
43353-742-982020-01-31C16284748780-19d75b9d0-9fac-f424-e053-dadaa90a57ceHYDRALAZINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-742-60Hydralazine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901
43353-742-80Hydralazine Hydrochloride180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1801
43353-742-92Hydralazine Hydrochloride270 in 1 BOTTLE, PLASTICTABLET, FILM COATED2701
43353-742-94Hydralazine Hydrochloride360 in 1 BOTTLE, PLASTICTABLET, FILM COATED3601
43353-742-96Hydralazine Hydrochloride450 in 1 BOTTLE, PLASTICTABLET, FILM COATED4501
43353-742-98Hydralazine Hydrochloride540 in 1 BOTTLE, PLASTICTABLET, FILM COATED5401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-742-60EA - Each43353-7425547e3ac-e2bd-4032-9ee5-550b82083f8b12014-08-01
43353-742-80EA - Each43353-7421103ec95-134c-4c11-8edc-e3b97345b51a12014-08-01
43353-742-92EA - Each43353-74258da71d3-b054-44c8-8918-7a271eeed92412014-08-01
43353-742-94EA - Each43353-7428de4ee46-018d-4aa9-a4df-d59768764d9412014-08-01
43353-742-96EA - Each43353-7427ec98760-3c07-4d17-9d92-bcc865a90cdf12014-08-01
43353-742-98EA - Each43353-742d1a9225f-773c-448d-a881-760a0448333612014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-742HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 6 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
43353-742-604335307426090 in 1 BOTTLE, PLASTICHistorical
43353-742-8043353074280180 in 1 BOTTLE, PLASTICHistorical
43353-742-9243353074292270 in 1 BOTTLE, PLASTICHistorical
43353-742-9443353074294360 in 1 BOTTLE, PLASTICHistorical
43353-742-9643353074296450 in 1 BOTTLE, PLASTICHistorical
43353-742-9843353074298540 in 1 BOTTLE, PLASTICHistorical