Hydralazine Hydrochloride

Product NDC
50090-4518
11-digit product format
500904518
Labeler code
50090
Product ID
50090-4518_4ae11709-79a6-449e-b8dc-20610546abf0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDRALAZINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
A-S Medication Solutions
Application
ANDA040388
Marketing category
ANDA
Marketing start
2001-09-05
Marketing end
0000-00-00
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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
50090-4518-02023-01-30C16284748780-1f386c64a-0e0b-0266-e053-dadaa90a7c1aHydralazine Hydrochloride Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4518-0Hydralazine Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4518-0ML - Milliliter50090-4518afdea65b-3f56-40ea-b608-d6c747fa5df112022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4518HYDRALAZINE HYDROCHLORIDE INJECTION [A-S MEDICATION SOLUTIONS]4Legacy NDC, 1 package rows20210417_c5647a72-22da-420a-a549-7b5185a621d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966571hydrALAZINE HCl 20 MG in 1 ML InjectionPSNc5647a72-22da-420a-a549-7b5185a621d44
9665711 ML hydralazine hydrochloride 20 MG/ML InjectionSCDc5647a72-22da-420a-a549-7b5185a621d44
966571hydralazine HCl 20 MG per 1 ML InjectionSYc5647a72-22da-420a-a549-7b5185a621d44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4518-0500904518001 mL in 1 VIAL, SINGLE-DOSE (50090-4518-0) 1 ml2019-09-110000-00-00NoNoCurrent