FDA.reportPublic FDA data

Hydralazine Hydrochloride

Product NDC
0517-0901
11-digit product format
005170901
Labeler code
0517
Product ID
0517-0901_5aca9ccd-3ac3-48b6-9372-34ee0eb4b7f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
American Regent, Inc.
Application
ANDA040136
Marketing category
ANDA
Marketing start
1997-06-30
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydralazine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDRALAZINE HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFD171B778Y
Rxcui966571

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
0517-0901-25Hydralazine Hydrochloride25 in 1 TRAYINJECTION, SOLUTION258
0517-0901-25Hydralazine Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-0901-25ML - Milliliter0517-09017ab8e644-ac86-4809-9209-72a48b8cb5d612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDRALAZINE HYDROCHLORIDEACTIVE INGREDIENTFD171B778YHYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]5
HYDRALAZINEACTIVE MOIETY26NAK24LS8HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]5
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBHYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RHYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-0901HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]8Current NDC, Legacy NDC, 2 package rows20190507_17210abc-58f6-442e-8ff2-7971333c82f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966571hydrALAZINE HCl 20 MG in 1 ML InjectionPSN17210abc-58f6-442e-8ff2-7971333c82f68
9665711 ML hydralazine hydrochloride 20 MG/ML InjectionSCD17210abc-58f6-442e-8ff2-7971333c82f68
966571hydralazine HCl 20 MG per 1 ML InjectionSY17210abc-58f6-442e-8ff2-7971333c82f68
966571hydrALAZINE HCl 20 MG in 1 ML InjectionPSN15b0f03b-b5a2-c49d-e063-6394a90a5b152
9665711 ML hydralazine hydrochloride 20 MG/ML InjectionSCD15b0f03b-b5a2-c49d-e063-6394a90a5b152
966571hydralazine HCl 20 MG per 1 ML InjectionSY15b0f03b-b5a2-c49d-e063-6394a90a5b152

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0517-0901-250051709012525 VIAL, SINGLE-DOSE in 1 TRAY (0517-0901-25) / 1 mL in 1 VIAL, SINGLE-DOSE1997-06-300000-00-00NoNoCurrent