FDA.reportPublic FDA data

hydrALAZINE Hydrochloride

Product NDC
70518-3659
11-digit product format
705183659
Labeler code
70518
Product ID
70518-3659_4f7186f4-e5c9-1555-e063-6294a90ad899
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrALAZINE Hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
REMEDYREPACK INC.
Application
ANDA040388
Marketing category
ANDA
Marketing start
2023-02-27
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
20 mg/mL
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 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
70518-3659-0hydrALAZINE Hydrochloride25 in 1 TRAYINJECTION253
70518-3659-0hydrALAZINE Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION13
70518-3659-1hydrALAZINE Hydrochloride25 in 1 TRAYINJECTION253
70518-3659-2hydrALAZINE Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3659HYDRALAZINE HYDROCHLORIDE INJECTION [REMEDYREPACK INC.]1Current NDC, 4 package rows20240922_dca82025-a4cd-4856-aa19-bdf091bf8973.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966571hydrALAZINE HCl 20 MG in 1 ML InjectionPSNdca82025-a4cd-4856-aa19-bdf091bf89733
9665711 ML hydralazine hydrochloride 20 MG/ML InjectionSCDdca82025-a4cd-4856-aa19-bdf091bf89733
966571hydralazine HCl 20 MG per 1 ML InjectionSYdca82025-a4cd-4856-aa19-bdf091bf89733

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3659-07051836590025 in 1 TRAYHistorical
70518-3659-17051836590125 VIAL, SINGLE-DOSE in 1 TRAY (70518-3659-1) / 1 mL in 1 VIAL, SINGLE-DOSE (70518-3659-2) 2024-09-19NoNoHistorical
70518-3659-2705183659021 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical