FDA.reportPublic FDA data

Hydralazine Hydrochloride

Product NDC
72572-265
11-digit product format
725720265
Labeler code
72572
Product ID
72572-265_c25506f2-689e-4053-b858-8424e6724ed6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Civica, Inc.
Application
ANDA040136
Marketing category
ANDA
Marketing start
2020-10-29
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
72572-265-01Hydralazine Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION14
72572-265-25Hydralazine Hydrochloride25 in 1 TRAYINJECTION, SOLUTION254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-265HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [CIVICA, INC.]4Current NDC, Legacy NDC, 2 package rows20240429_ffa483a4-de2a-4d42-ad27-afacd37f28e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966571hydrALAZINE HCl 20 MG in 1 ML InjectionPSNffa483a4-de2a-4d42-ad27-afacd37f28e44
9665711 ML hydralazine hydrochloride 20 MG/ML InjectionSCDffa483a4-de2a-4d42-ad27-afacd37f28e44
966571hydralazine HCl 20 MG per 1 ML InjectionSYffa483a4-de2a-4d42-ad27-afacd37f28e44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-265-01725720265011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
72572-265-257257202652525 VIAL, SINGLE-DOSE in 1 TRAY (72572-265-25) / 1 mL in 1 VIAL, SINGLE-DOSE (72572-265-01) 2020-10-290000-00-00NoNoCurrent