FDA.reportPublic FDA data

Hydralazine Hydrochloride

Product NDC
23155-834
11-digit product format
231550834
Labeler code
23155
Product ID
23155-834_c0c6a9c0-15c8-408d-b398-3fb16e0f8cd3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA040858
Marketing category
ANDA
Marketing start
2023-08-02
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydralazine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDRALAZINE HYDROCHLORIDE50 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
23155-834-01Hydralazine Hydrochloride100 in 1 BOTTLETABLET1003
23155-834-10Hydralazine Hydrochloride1000 in 1 BOTTLETABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-834-01EA - Each23155-83417b14718-2f93-42fd-ba35-d3a0638e789612023-10-16
23155-834-10EA - Each23155-8347255c441-29dd-43b5-bccf-cdb6c1c2a50012023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-834HYDRALAZINE HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]2Current NDC, 2 package rows20250129_669532c9-ba15-4f4b-95a8-13782deb3521.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905199hydrALAZINE HCl 10 MG Oral TabletPSN669532c9-ba15-4f4b-95a8-13782deb35213
905222hydrALAZINE HCl 100 MG Oral TabletPSN669532c9-ba15-4f4b-95a8-13782deb35213
905225hydrALAZINE HCl 25 MG Oral TabletPSN669532c9-ba15-4f4b-95a8-13782deb35213
905395hydrALAZINE HCl 50 MG Oral TabletPSNd61ffa06-8138-4a1d-9530-095a80d9c9ce3
905395hydrALAZINE HCl 50 MG Oral TabletPSN669532c9-ba15-4f4b-95a8-13782deb35213
905199hydralazine hydrochloride 10 MG Oral TabletSCD669532c9-ba15-4f4b-95a8-13782deb35213
905222hydralazine hydrochloride 100 MG Oral TabletSCD669532c9-ba15-4f4b-95a8-13782deb35213
905225hydralazine hydrochloride 25 MG Oral TabletSCD669532c9-ba15-4f4b-95a8-13782deb35213
905395hydralazine hydrochloride 50 MG Oral TabletSCD669532c9-ba15-4f4b-95a8-13782deb35213
905395hydralazine hydrochloride 50 MG Oral TabletSCDd61ffa06-8138-4a1d-9530-095a80d9c9ce3
905199hydrALAZINE HCl 10 MG Oral TabletPSN2e82655e-8435-46fa-b734-8e7c6e8034532
905199hydrALAZINE HCl 10 MG Oral TabletPSNb6ccd35e-f69c-4eef-a456-905e030ae9112
905222hydrALAZINE HCl 100 MG Oral TabletPSNb6ccd35e-f69c-4eef-a456-905e030ae9112
905225hydrALAZINE HCl 25 MG Oral TabletPSNb6ccd35e-f69c-4eef-a456-905e030ae9112
905225hydrALAZINE HCl 25 MG Oral TabletPSN2e82655e-8435-46fa-b734-8e7c6e8034532
905395hydrALAZINE HCl 50 MG Oral TabletPSN2e82655e-8435-46fa-b734-8e7c6e8034532
905395hydrALAZINE HCl 50 MG Oral TabletPSNb6ccd35e-f69c-4eef-a456-905e030ae9112
905199hydralazine hydrochloride 10 MG Oral TabletSCD2e82655e-8435-46fa-b734-8e7c6e8034532
905199hydralazine hydrochloride 10 MG Oral TabletSCDb6ccd35e-f69c-4eef-a456-905e030ae9112
905222hydralazine hydrochloride 100 MG Oral TabletSCDb6ccd35e-f69c-4eef-a456-905e030ae9112
905225hydralazine hydrochloride 25 MG Oral TabletSCDb6ccd35e-f69c-4eef-a456-905e030ae9112
905225hydralazine hydrochloride 25 MG Oral TabletSCD2e82655e-8435-46fa-b734-8e7c6e8034532
905395hydralazine hydrochloride 50 MG Oral TabletSCD2e82655e-8435-46fa-b734-8e7c6e8034532
905395hydralazine hydrochloride 50 MG Oral TabletSCDb6ccd35e-f69c-4eef-a456-905e030ae9112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
23155-834-0123155083401100 TABLET in 1 BOTTLE (23155-834-01) 100 tablet2023-08-02NoNoCurrent
23155-834-10231550834101000 TABLET in 1 BOTTLE (23155-834-10) 1000 tablet2023-08-02NoNoCurrent