FDA.reportPublic FDA data

Hydralazine Hydrochloride

Product NDC
70518-4064
11-digit product format
705184064
Labeler code
70518
Product ID
70518-4064_4c994e23-d3bb-f74a-e063-6294a90a6f1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA040858
Marketing category
ANDA
Marketing start
2024-05-04
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
25 mg/1
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 HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFD171B778Y
Rxcui905225

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
70518-4064-0Hydralazine Hydrochloride30 in 1 BLISTER PACKTABLET307
70518-4064-1Hydralazine Hydrochloride30 in 1 BLISTER PACKTABLET307
70518-4064-2Hydralazine Hydrochloride180 in 1 BOTTLE, PLASTICTABLET1807
70518-4064-3Hydralazine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4064HYDRALAZINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]2Current NDC, 4 package rows20241225_6c40d818-77a9-492c-b9b6-d8a0fe8d6736.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905225hydrALAZINE HCl 25 MG Oral TabletPSN6c40d818-77a9-492c-b9b6-d8a0fe8d67367
905225hydralazine hydrochloride 25 MG Oral TabletSCD6c40d818-77a9-492c-b9b6-d8a0fe8d67367

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4064-07051840640030 in 1 BLISTER PACKHistorical
70518-4064-17051840640130 in 1 BLISTER PACKHistorical
70518-4064-270518406402180 TABLET in 1 BOTTLE, PLASTIC (70518-4064-2) 180 tablet2025-05-28NoNoCurrent
70518-4064-37051840640390 TABLET in 1 BOTTLE, PLASTIC (70518-4064-3) 90 tablet2025-07-01NoNoCurrent