FDA.reportPublic FDA data

HYDRALAZINE HYDROCHLORIDE

Product NDC
51662-1648
11-digit product format
516621648
Labeler code
51662
Product ID
51662-1648_15b1adc3-9cb5-cf06-e063-6294a90a1da7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDRALAZINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
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
51662-1648-2HYDRALAZINE HYDROCHLORIDE1 in 1 POUCHINJECTION, SOLUTION12
51662-1648-2HYDRALAZINE HYDROCHLORIDE1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION12
51662-1648-3HYDRALAZINE HYDROCHLORIDE25 in 1 CASEINJECTION, SOLUTION252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1648HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]2Current NDC, 3 package rows20240410_15b0f03b-b5a2-c49d-e063-6394a90a5b15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
51662-1648-2516621648021 in 1 POUCHHistorical
51662-1648-35166216480325 POUCH in 1 CASE (51662-1648-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1648-2) / 1 mL in 1 VIAL, SINGLE-DOSE25 pouch1997-06-30NoNoCurrent