FDA.reportPublic FDA data

Hydralazine Hydrochloride

Product NDC
70518-2551
11-digit product format
705182551
Labeler code
70518
Product ID
70518-2551_4a67249e-ac1c-3ea4-e063-6394a90a3fc5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA040901
Marketing category
ANDA
Marketing start
2020-01-22
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
70518-2551-0Hydralazine Hydrochloride30 in 1 BLISTER PACKTABLET3013
70518-2551-1Hydralazine Hydrochloride30 in 1 BLISTER PACKTABLET3013
70518-2551-2Hydralazine Hydrochloride180 in 1 BOTTLE, PLASTICTABLET18013
70518-2551-3Hydralazine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET9013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2551HYDRALAZINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 4 package rows20250501_89afc8ef-27c4-489a-81de-3f8f65f6bbb8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905225hydrALAZINE HCl 25 MG Oral TabletPSN89afc8ef-27c4-489a-81de-3f8f65f6bbb813
905225hydralazine hydrochloride 25 MG Oral TabletSCD89afc8ef-27c4-489a-81de-3f8f65f6bbb813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2551-07051825510030 TABLET in 1 BLISTER PACK (70518-2551-0) 30 tablet2020-01-220000-00-00NoNoCurrent
70518-2551-17051825510130 TABLET in 1 BLISTER PACK (70518-2551-1) 30 tablet2025-07-31NoNoHistorical
70518-2551-270518255102180 TABLET in 1 BOTTLE, PLASTIC (70518-2551-2) 180 tablet2025-09-04NoNoHistorical
70518-2551-37051825510390 TABLET in 1 BOTTLE, PLASTIC (70518-2551-3) 90 tablet2025-09-04NoNoHistorical