FDA.reportPublic FDA data

HYDRALAZINE HYDROCHLORIDE

Product NDC
23155-001
11-digit product format
231550001
Labeler code
23155
Product ID
23155-001_e092716d-6522-4cfb-8728-622f9b553ef1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydralazine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA086242
Marketing category
ANDA
Marketing start
2007-04-06
Marketing end
2026-08-31
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFD171B778Y
Rxcui905199, 905222, 905225, 905395

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-001-01HYDRALAZINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED10017
23155-001-10HYDRALAZINE HYDROCHLORIDE1000 in 1 BOTTLETABLET, FILM COATED100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-001-01EA - Each23155-00157e88b6a-a807-4427-a69d-3eb5f230e38812012-07-24
23155-001-10EA - Each23155-001821fef2b-2460-4cbc-a2af-3e758f4341f512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC]8
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC]8
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC]8
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC]8
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC]8
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-001HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]15Current NDC, Legacy NDC, 2 package rows20231130_a04eefaf-ba3c-448d-8ece-4aa9ab2e3508.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905199hydrALAZINE HCl 10 MG Oral TabletPSNa04eefaf-ba3c-448d-8ece-4aa9ab2e350817
905222hydrALAZINE HCl 100 MG Oral TabletPSNa04eefaf-ba3c-448d-8ece-4aa9ab2e350817
905225hydrALAZINE HCl 25 MG Oral TabletPSNa04eefaf-ba3c-448d-8ece-4aa9ab2e350817
905395hydrALAZINE HCl 50 MG Oral TabletPSNa04eefaf-ba3c-448d-8ece-4aa9ab2e350817
905199hydralazine hydrochloride 10 MG Oral TabletSCDa04eefaf-ba3c-448d-8ece-4aa9ab2e350817
905222hydralazine hydrochloride 100 MG Oral TabletSCDa04eefaf-ba3c-448d-8ece-4aa9ab2e350817
905225hydralazine hydrochloride 25 MG Oral TabletSCDa04eefaf-ba3c-448d-8ece-4aa9ab2e350817
905395hydralazine hydrochloride 50 MG Oral TabletSCDa04eefaf-ba3c-448d-8ece-4aa9ab2e350817
905199hydrALAZINE HCl 10 MG Oral TabletPSNb44f38da-edd2-45f7-8c26-73d01ffa86b63
905222hydrALAZINE HCl 100 MG Oral TabletPSNb44f38da-edd2-45f7-8c26-73d01ffa86b63
905225hydrALAZINE HCl 25 MG Oral TabletPSNb44f38da-edd2-45f7-8c26-73d01ffa86b63
905395hydrALAZINE HCl 50 MG Oral TabletPSNb44f38da-edd2-45f7-8c26-73d01ffa86b63
905199hydralazine hydrochloride 10 MG Oral TabletSCDb44f38da-edd2-45f7-8c26-73d01ffa86b63
905222hydralazine hydrochloride 100 MG Oral TabletSCDb44f38da-edd2-45f7-8c26-73d01ffa86b63
905225hydralazine hydrochloride 25 MG Oral TabletSCDb44f38da-edd2-45f7-8c26-73d01ffa86b63
905395hydralazine hydrochloride 50 MG Oral TabletSCDb44f38da-edd2-45f7-8c26-73d01ffa86b63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
23155-001-0123155000101100 TABLET, FILM COATED in 1 BOTTLE (23155-001-01) 2007-04-062026-08-31NoNoCurrent
23155-001-10231550001101000 TABLET, FILM COATED in 1 BOTTLE (23155-001-10) 2007-04-062026-08-31NoNoCurrent